No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B330OF03480 | OF-0348 | Osseoflex® CD-H Hydraulic Cement Delivery system is a bone cement delivery devic Osseoflex® CD-H Hydraulic Cement Delivery system is a bone cement delivery device designed to allow the physician to keep a safer distance from the radiation source during the cement delivery phase in vertebroplasty, vertebral augmentation procedures and the skeletal system. | KIH | Dispenser, Cement | 1 | Osseoflex CD-H | |
2 | B330PC02700 | PC-0270 | The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt can The Osseoflex PC Pre-Curved Bone Tamp is a mechanical device used to disrupt cancellous bone by channeling through the bone creating a void within a vertebral body. The Osseoflex PC Pre-Curved Bone Tamp can be utilized for multiple level vertebral body access. The channel can be used to introduce an appropriately sized Osseon inflatable bone tamp. | HXG | Tamp | 1 | Osseoflex PC Pre-Curved Bone Tamp 10ga | |
3 | 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. | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Osseoflex SB Steerable Balloon (10ga/2ml) | |
4 | 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. | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Osseoflex SB Straight Balloon (10ga/4ml) | |
5 | 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. | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Osseoflex SB Steerable Balloon (8ga/2ml) | |
6 | 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. | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) | |
7 | 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. | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Osseoflex SB Steerable Balloon (8ga/ 4ml) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817470000290 | ASC5050-01 | ASC5050-01 | KVAC STANDARD WAND | KVAC | SMITH & NEPHEW, INC. |
2 | 00817470000252 | ASHA5050-01 | ASHA5050-01 | AMBIENT KVAC IFS WAND | KVAC | SMITH & NEPHEW, INC. |
3 | 00815212026362 | G80007E | Bone Filler Kit-HV EU | IZI MEDICAL PRODUCTS, LLC | ||
4 | 00815212025570 | G80007 | OS Bone Filler Kit-HV | IZI MEDICAL PRODUCTS, LLC | ||
5 | 00815212024627 | G90005 | Cement: Vertefix HV | IZI MEDICAL PRODUCTS, LLC | ||
6 | 00815212024559 | VA1112 | Osteo-site Vertebral Augmentation Introducer 11G | IZI MEDICAL PRODUCTS, LLC | ||
7 | 00815212024542 | VA1012 | Osteo-site Verbebral Augmentation Introducer 10G | IZI MEDICAL PRODUCTS, LLC | ||
8 | 00815212024535 | G10015 | BKP-10-12.0-15.0 | IZI MEDICAL PRODUCTS, LLC | ||
9 | 00815212024535 | G10015 | BKP-10-12.0-15.0 | IZI MEDICAL PRODUCTS, LLC | ||
10 | 00815212024450 | KIVA2200E | KIT: VCF Treatment, LEFT, FRACTURE | IZI MEDICAL PRODUCTS, LLC | ||
11 | 00815212024443 | KIVA2100E | KIT: VCF Treatment, RIGHT, FRACTURE | IZI MEDICAL PRODUCTS, LLC | ||
12 | 00815212024429 | G80004 | VCF-400 | IZI MEDICAL PRODUCTS, LLC | ||
13 | 00815212024399 | G11015 | BKP-11-12.0-15.0 | IZI MEDICAL PRODUCTS, LLC | ||
14 | 00815212024399 | G11015 | BKP-11-12.0-15.0 | IZI MEDICAL PRODUCTS, LLC | ||
15 | 00815212023439 | VBC-100-PL-US | VBC-100-PL-US | VERTEFIX Plus US | TEKNIMED | |
16 | 00815212021404 | G80005 | G80005 | Bone Filler Kit | IZI MEDICAL PRODUCTS, LLC | |
17 | 00815212021374 | G80006 | G80006 | Spinoplasty Kit | IZI MEDICAL PRODUCTS, LLC | |
18 | 00813892020670 | AS-570 | AS-570 | 5mm 70º Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
19 | 00813892020663 | AS-230 | AS-230 | 4mm 30º Long Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
20 | 00813892020656 | AS-175 | AS-175 | 3mm 30º Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
21 | 00813892020649 | AS-070 | AS-070 | 3mm 70º Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
22 | 00813892020632 | AS-050 | AS-050 | 5mm 30º Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
23 | 00813892021424 | AS-370 | AS-370 | 3mm 70º Non-Locking Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
24 | 00813892021110 | AS-330 | AS-330 | 3mm 30º Non-Locking Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
25 | 00813892021103 | AS-300 | AS-300 | 3mm 0º Non-Locking Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
26 | 00813892021097 | AS-175S | AS-175S | 3mm 30º Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
27 | 00813892021080 | AS-400 | AS-400 | 4mm 0º Long Arthroscope | Q System Arthroscope | ORTHOPEDIC SCIENCES INC |
28 | 00813478020438 | MS3101 | MS3101 | Verterbral Augmentation Cement | Kiva | BENVENUE MEDICAL, INC. |
29 | 00813478020421 | MS2079 | MS2079 | F20 Radiopaque Bone Cement | Blazer | BENVENUE MEDICAL, INC. |
30 | 00813478020247 | VAK1700 | VAK1700 | Vertebral Augmentation Cement Kit for Use with Blazer-C | Blazer | BENVENUE MEDICAL, INC. |
31 | 00813478020179 | VAK1800 | VAK1800 | Vertebral Augmentation Cement Kit for Use with Kiva | Kiva | BENVENUE MEDICAL, INC. |
32 | 00813478020056 | FRS2200 | FRS2200 | Kiva VCF Treatment System, First Fracture, Left | Kiva | BENVENUE MEDICAL, INC. |
33 | 00813478020049 | FRS2100 | FRS2100 | Kiva VCF Treatment System, First Fracture, Right | Kiva | BENVENUE MEDICAL, INC. |
34 | 00813478020032 | KIV2250 | KIV2250 | Kiva VCF Treatment System, Additional Fracture Kit, Left | Kiva | BENVENUE MEDICAL, INC. |
35 | 00813478020025 | KIV2200 | KIV2200 | Kiva VCF Treatment System, First Fracture Kit, Left | Kiva | BENVENUE MEDICAL, INC. |
36 | 00813478020018 | KIV2150 | KIV2150 | Kiva VCF Treatment System, Additional Fracture Kit, Right | Kiva | BENVENUE MEDICAL, INC. |
37 | 00813478020001 | KIV2100 | KIV2100 | Kiva VCF Treatment System, Fisrt Fracture Kit, Right | Kiva | BENVENUE MEDICAL, INC. |
38 | 00812231031261 | 84-14-2770 | 84-14-2770 | ARTHROSCOPE, 2.7MM 70DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
39 | 00812231031254 | 84-14-2730 | 84-14-2730 | ARTHROSCOPE, 2.7MM 30DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
40 | 00812231031247 | 84-14-2700 | 84-14-2700 | ARTHROSCOPE, 2.7MM 0DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
41 | 00812231031230 | 84-14-1930 | 84-14-1930 | ARTHROSCOPE, 1.9MM 30DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
42 | 00812231031223 | 84-14-1900 | 84-14-1900 | ARTHROSCOPE, 1.9MM 0DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
43 | 00812231030950 | 84-14-2870 | 84-14-2870 | C-MOUNT ARTHROSCOPE, 2.7MM 70DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
44 | 00812231030943 | 84-14-2830 | 84-14-2830 | C-MOUNT ARTHROSCOPE, 2.7MM 30DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
45 | 00812231030936 | 84-14-2800 | 84-14-2800 | C-MOUNT ARTHROSCOPE, 2.7MM 0DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
46 | 00812231030929 | 84-14-2030 | 84-14-2030 | C-MOUNT ARTHROSCOPE, 1.9MM 30DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
47 | 00812231030912 | 84-14-2000 | 84-14-2000 | C-MOUNT ARTHROSCOPE, 1.9MM 0DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
48 | 00812231030462 | 84-14-4000 | 84-14-4000 | 4K ARTHROSCOPE, 4MM 0DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
49 | 00812231030455 | 84-14-4170 | 84-14-4170 | 4K C-MOUNT ARTHROSCOPE, 4MM 70DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |
50 | 00812231030448 | 84-14-4100 | 84-14-4100 | 4K C-MOUNT ARTHROSCOPE, 4MM 0DEG | ZEOS | SANTA BARBARA IMAGING SYSTEMS, INC. |