| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850696006677 | RF-1015L-01 | RF-1015L-01 | blister tray packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (10 15, Long) with PowerCURVE |
| 2 | 00850696006530 | 3353 | 3353 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT First Fracture Kit | |
| 3 | 00850696006523 | 2003 | 2003 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT First Fracture Kit | |
| 4 | 00850696006271 | RF-1015L-01 | RF-1015L-01 | ala carte packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (10 15, Long) with PowerCURVE |
| 5 | 00850696006233 | 3353-01 | 3353-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT First Fracture Kit | |
| 6 | 00850696006226 | 2003-1 | 2003-1 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT First Fracture Kit | |
| 7 | 00850696006639 | MX-2100L-01 | MX-2100L-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 8 | 00850696006622 | MX-2100S-01 | MX-2100S-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 9 | 00850696006615 | MX-1100L-01 | MX-1100L-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 10 | 00850696006660 | RF-1015S-01 | RF-1015S-01 | blister tray packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (10 15, Short) with PowerCURVE |
| 11 | 00850696006608 | MX-1100S-01 | MX-1100S | Blister tray packaging | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit |
| 12 | 00850696006493 | MX-2100L | MX-2100L | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 13 | 00850696006486 | MX-2100S | MX-2100S | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 14 | 00850696006479 | MX-1100L | MX-1100L | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 15 | 00850696006462 | MX-1100S | MX-1100S | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 16 | 00850696006417 | 1135 | 1135 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT ER2 Bone Cement | |
| 17 | 00850696006318 | MX-1100S-01 | MX-1100S | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 18 | 00850696006301 | MX-1100L-01 | MX-1100S | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 19 | 00850696006295 | MX-2100S-01 | MX-1100S | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT MX Fracture Kit | |
| 20 | 00850696006240 | RF-1015S-01 | RF-1015S-01 | ala carte packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (10 15, Short) with PowerCURVE |
| 21 | 00850696006004 | STR-1015L | STR-1015L | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | SpineSTAR Ablation Instrument (10 15, Long) | |
| 22 | 00850696006691 | 3192 | 3192 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | SpineSTAR Ablation Instrument (10 15, Short) | |
| 23 | 00850696006424 | 1688 | 1688 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT ER2 Bone Cement and Saturate Mixing System | |
| 24 | 00850696006653 | RF-0510L-01 | RF-0510L-01 | blister tray packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (5 10, Long) with PowerCURVE |
| 25 | 00850696006455 | VP-1110L | VP-1110L | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT VP Vertebroplasty Kit | |
| 26 | 00850696006448 | VP-1110S | VP-1110S | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT VP Vertebroplasty Kit | |
| 27 | 00850696006431 | 3366 | 3366 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT ER2 Bone Cement, Single - Level | |
| 28 | 00850696006257 | RF-0510L-01 | RF-0510L-01 | ala carte packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (5 10, Long) with PowerCURVE |
| 29 | 00850696006073 | VP-0010A | VP-0010A | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT VP Fracture Kit | |
| 30 | 00850696006011 | STR-0510L | STR-0510L | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | SpineSTAR Ablation Instrument (5 10, Long) | |
| 31 | 00850696006646 | RF-0510S-01 | RF-0510S-01 | blister tray packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (5 10, Short) with PowerCURVE |
| 32 | 00850696006516 | 1666 | 1666 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Second Fracture Kit | |
| 33 | 00850696006394 | 1666-01 | 1666-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Second Fracture Kit | |
| 34 | 00850696006264 | RF-0510S-01 | RF-0510S-01 | ala carte packaging | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | STAR Tumor Ablation Kit (5 10, Short) with PowerCURVE |
| 35 | 00850696006028 | 4457 | 4457 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Bone Cement and Saturate Mixing System | |
| 36 | 00850696006684 | 3544 | 3544 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | SpineSTAR Ablation Instrument (5 10, Short) | |
| 37 | 00850696006509 | 1436 | 1436 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Second Fracture Kit | |
| 38 | 00850696006400 | 1436-01 | 1436-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Second Fracture Kit | |
| 39 | 00850696006554 | 3512 | 3512 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Complete Fracture Kit | |
| 40 | 00850696006547 | 3506 | 3506 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Complete Fracture Kit | |
| 41 | 00850696006387 | 3512-01 | 3512-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Complete Fracture Kit | |
| 42 | 00850696006370 | 3506-01 | 3506-01 | NDN | Cement, Bone, Vertebroplasty | 2 | StabiliT Complete Fracture Kit |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00643169097865 | C01A | BONE CEMENT C01A HV-R US | KYPHON® HV-R® Bone Cement | MEDTRONIC SOFAMOR DANEK, INC. | |
| 2 | 00643169097834 | C01B | BONE CEMENT C01B HV-R WITH MIXER US | KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack | MEDTRONIC SOFAMOR DANEK, INC. | |
| 3 | 00643169097810 | C10A | BONE CEMENT C10A KYPHON ACTIVOS 10 | ActivOs™ 10 Bone Cement | MEDTRONIC SOFAMOR DANEK, INC. | |
| 4 | 00643169097803 | CX01A | BONE CEMENT CX01A XPEDE US | KYPHON® Xpede™ Bone Cement | MEDTRONIC SOFAMOR DANEK, INC. | |
| 5 | 00643169097797 | CX01B | BONE CEMENT CX01B XPEDE W MIXER US | KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack | MEDTRONIC SOFAMOR DANEK, INC. | |
| 6 | 00613994831507 | CX01B | BONE CEMENT CX01B KYPHON XPEDE W MXR US | KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack | MEDTRONIC SOFAMOR DANEK, INC. | |
| 7 | 00613994746931 | C10A | BONE CEMENT C10A KYPHON ACTIVOS 10 | ActivOs™ 10 Bone Cement | MEDTRONIC SOFAMOR DANEK, INC. | |
| 8 | 00613994745606 | C01A | BONE CEMENT C01A HV-R CAN | KYPHON® HV-R® Bone Cement | MEDTRONIC SOFAMOR DANEK, INC. | |
| 9 | 00613994745590 | C01A | BONE CEMENT C01A HV-R US | KYPHON® HV-R® Bone Cement | MEDTRONIC SOFAMOR DANEK, INC. | |
| 10 | 00613994745569 | C01B | BONE CEMENT C01B HV-R WITH MIXER CAN | KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack | MEDTRONIC SOFAMOR DANEK, INC. | |
| 11 | 00613994745552 | C01B | BONE CEMENT C01B HV-R WITH MIXER US | KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack | MEDTRONIC SOFAMOR DANEK, INC. | |
| 12 | 00613994583215 | C01A | CEMENT C01A KYPHX HV-R BONE CEMENT EN | KYPHON® HV-R® Bone Cement | MEDTRONIC SOFAMOR DANEK, INC. | |
| 13 | 00613994515155 | C01B | BONE CEMENT C01B HV-R WITH MIXER US | KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack | MEDTRONIC SOFAMOR DANEK, INC. | |
| 14 | B330OT02240 | OT-0224 | The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex SB is designed to follow a pre-existing channel created by an access channel device. If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. | Osseoflex SB Straight Balloon (10ga/4ml) | OSSEON LLC | |
| 15 | B330OT02220 | OT-0222 | The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. | Osseoflex SB Straight Balloon (10ga/2ml) | OSSEON LLC | |
| 16 | B330OF82220 | OF-8222 | The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. | Osseoflex SB Steerable Balloon (8ga/2ml) | OSSEON LLC | |
| 17 | B330OF02240 | OF-0224 | The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. | Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) | OSSEON LLC | |
| 18 | B330OF02220 | OF-0222 | The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN steerable needle to fill the previously created void(s). An access channel is required for the Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.If the balloon has an Articulating Stylet inserted it enables the steerable feature of the balloon. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existing channel. The Osseoflex® SB actuation knob can be turned clockwise to aid in directing the distal portion of the device. Turning the actuation knob counter-clockwise will relax the device and allow the device to be returned to it's start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. | Osseoflex SB Steerable Balloon (10ga/2ml) | OSSEON LLC | |
| 19 | B330OF00050 | OF-0005 | The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® SN+ steerable needle to fill the previously created void(s).An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device through the pre-existingchannel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images. | Osseoflex SB Steerable Balloon (8ga/ 4ml) | OSSEON LLC | |
| 20 | 30808232000949 | 2110-0031 | 2110-0031 | Mix Tips, Luer | Cortoss | STRYKER CORPORATION |
| 21 | 28031497001382 | 13C2040 | Mendec Spine HV System is indicated for the treatment of pathological fractures Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine HV System is a closed sysyem which containes the powder and liquid components separately.The device is disposable and sterile. | Mendec Spine HV System | TECRES SPA | |
| 22 | 28031497000521 | 13C2000 | Mendec Spine Kit is a device for the treatment of pathological fractures of the Mendec Spine Kit is a device for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure.The device is composed by an acrylic resin and a delivery system. | Mendec Spine Kit | TECRES SPA | |
| 23 | 28031497000101 | 1230 | Mendec Spine is an acrylic resin for the treatment of pathological fractures of Mendec Spine is an acrylic resin for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine is a medium-high viscosity acrylic resin (PMMA-based), highly radiopaque for syringe application.The device is sold disposable and sterile | Mendec Spine | TECRES SPA | |
| 24 | 15056033810538 | INTV-CEM | Osteoflex | PAN MEDICAL US CORPORATION | ||
| 25 | 10885403242021 | VBT1110 | VBT1110 | AVAMAX™ VERTEBRAL BALLOON TRAY 11GX10MM | AVAmax | CAREFUSION 2200, INC |
| 26 | 10885403241192 | AFB1130 | AFB1130 | AVAFLEX™ VERTEBRAL BALLOON SYSTEM 11GX30MM | AVAflex | CAREFUSION 2200, INC |
| 27 | 10885403241185 | AFB1120 | AFB1120 | AVAFLEX™ VERTEBRAL BALLOON SYSTEM 11GX20MM | AVAflex | CAREFUSION 2200, INC |
| 28 | 10885403241178 | AFB1115 | AFB1115 | AVAFLEX™ VERTEBRAL BALLOON SYSTEM 11GX15MM | AVAflex | CAREFUSION 2200, INC |
| 29 | 10885403240911 | VBT1320 | VBT1320 | AVAMAX™ VERTEBRAL BALLOON TRAY 13GX20MM | AVAmax | CAREFUSION 2200, INC |
| 30 | 10885403240904 | VBT1315 | VBT1315 | AVAMAX™ VERTEBRAL BALLOON TRAY 13GX15MM | AVAmax | CAREFUSION 2200, INC |
| 31 | 10885403240898 | VBT1310 | VBT1310 | AVAMAX™ VERTEBRAL BALLOON TRAY 13GX10MM | AVAmax | CAREFUSION 2200, INC |
| 32 | 10885403225796 | AFB1030 | AFB1030 | AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX20MM | AVAflex | CAREFUSION 2200, INC |
| 33 | 10885403223259 | AFB1015 | AFB1015 | AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX15MM | AVAflex | CAREFUSION 2200, INC |
| 34 | 10885403223242 | AFB1020 | AFB1020 | AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX20MM | AVAflex | CAREFUSION 2200, INC |
| 35 | 10885403176593 | VBT1120 | VBT1120 | AVAMAX™ VERTEBRAL BALLOON TRAY 11GX20MM | AVAmax | CAREFUSION 2200, INC |
| 36 | 10885403176586 | VBT1115 | VBT1115 | AVAMAX™ VERTEBRAL BALLOON TRAY 11GX15MM | AVAmax | CAREFUSION 2200, INC |
| 37 | 10885403120022 | VBT1015 | VBT1015 | AVAMAX™ VERTEBRAL BALLOON TRAY 10GX15MM | AVAmax | CAREFUSION 2200, INC |
| 38 | 10885403119996 | VBT1010 | VBT1010 | AVAMAX™ VERTEBRAL BALLOON TRAY 10GX10MM | AVAmax | CAREFUSION 2200, INC |
| 39 | 10885403119804 | VBT1020 | VBT1020 | AVAMAX™ VERTEBRAL BALLOON TRAY 10GX20MM | AVAmax | CAREFUSION 2200, INC |
| 40 | 10885403002120 | VMXXLCT | VMXXLCT | AVAmax PLUS Extra Level Tray Bone Cement Delivery System | AVAmax | CAREFUSION 2200, INC |
| 41 | 10885403002113 | VMX00CT | VMX00CT | AVAmax PLUS Bone Cement Delivery System | AVAmax | CAREFUSION 2200, INC |
| 42 | 10885403002106 | BCTXLCT | BCTXLCT | AVAmax Extra Level Tray, Bone Cement Delivery System | AVAmax | CAREFUSION 2200, INC |
| 43 | 10885403002090 | BCT00CT | BCT00CT | AVAmax Bone Cement Delivery System | AVAmax | CAREFUSION 2200, INC |
| 44 | 10885403002069 | BCPM003 | BCPM003 | AVAtex Radiopaque Bone Cement | AVAtex | CAREFUSION 2200, INC |
| 45 | 10885403001932 | VBT0820 | VBT0820 | AVAMAX™ VERTEBRAL BALLOON TRAY 8GX20MM | AVAmax | CAREFUSION 2200, INC |
| 46 | 10885403001925 | VBT0815 | VBT0815 | AVAMAX™ VERTEBRAL BALLOON TRAY 8GX15MM | AVAmax | CAREFUSION 2200, INC |
| 47 | 10885403001918 | VBT0810 | VBT0810 | AVAMAX™ VERTEBRAL BALLOON TRAY 8GX10MM | AVAmax | CAREFUSION 2200, INC |
| 48 | 10827002432007 | G43200 | CVAK-100 | Vertebroplasty Ancillary Kit | Cook | COOK INCORPORATED |
| 49 | 10705034722726 | 03.804.702S | 03804702S | SYNFLATE BALLOON/LARGE- STERILE | SYNFLATE | SYNTHES GMBH |
| 50 | 10705034722719 | 03.804.701S | 03804701S | SYNFLATE BALLOON/MEDIUM- STERILE | SYNFLATE | SYNTHES GMBH |