No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00856719002879 | TCT2-000 | TCT2-000 | Orthopedic surgical instrument - Trocar, Long | HWJ | Awl | 1 | PRECICE® Instruments |
2 | 00856719002862 | GTT2-000 | GTT2-000 | Orthopedic surgical instrument - Guide tube | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
3 | 00856719002855 | DST2-000 | DST2-000 | Orthopedic surgical instrument - Drill sleeve, long | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
4 | 00856719002251 | THD3-000 | THD3-000 | Orthopedic surgical instrument - NuVa T-Handle, J-Hall | LXH | Orthopedic Manual Surgical Instrument | 1 | PRECICE® Instruments |
5 | 00856719002213 | P003 | EAD-P1-213 | ERC1, PRECICE, Shipping Pkg KOR | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
6 | 00856719002206 | P003 | EAD-P1-113 | ERC1, PRECICE, Shipping Pkg GER | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
7 | 00856719002060 | P003 | EAD-P1-013 | ERC1, PRECICE, Shipping Pkg EU | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
8 | 00856719002053 | P003 | EAD-P1-012 | ERC1, PRECICE, Shipping Pkg UK | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
9 | 00856719002046 | P003 | EAD-P1-011 | ERC1, PRECICE, Shipping Pkg AR | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
10 | 00856719002022 | P003 | EAD-P1-003 | ERC1, MAGEC, Shipping Pkg EU | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
11 | 00856719002015 | P003 | EAD-P1-002 | ERC1, MAGEC, Shipping Pkg UK | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
12 | 00856719002008 | P003 | EAD-P1-001 | ERC1, MAGEC, Shipping Pkg AR | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
13 | 00812258029302 | P003 | EAD-P1-014 | ERC1, PRECICE, Shipping Pkg AU | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
14 | 00812258029203 | DMS2-000 | DMS2-000 | Orthopedic surgical instrument - Direct measuring sleeve | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
15 | 00812258029197 | XRR2-000 | XRR2-000 | Orthopedic surgical instrument - Radiographic ruler | FTY | Tape, Measuring, Rulers And Calipers | 1 | PRECICE® Instruments |
16 | 00812258029180 | STS2-000 | STS2-000 | Orthopedic surgical instrument - Soft tissue protector tube | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
17 | 00812258029173 | SET2-001 | SET2-001 | Orthopedic surgical instrument - Guide wire sleeve | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
18 | 00812258029166 | SDS2-001 | SDS2-001 | Orthopedic surgical instrument - Screw driver, 3.5 mm, short solid | HXX | Screwdriver | 1 | PRECICE® Instruments |
19 | 00812258029159 | SDS2-000 | SDS2-000 | Orthopedic surgical instrument - Screw driver, 3.5 mm, short cannulated | HXX | Screwdriver | 1 | PRECICE® Instruments |
20 | 00812258029142 | SDL2-001 | SDL2-001 | Orthopedic surgical instrument - Screw driver, 3.5 mm, long solid | HXX | Screwdriver | 1 | PRECICE® Instruments |
21 | 00812258029135 | SDL2-000 | SDL2-000 | Orthopedic surgical instrument - Screw driver, 3.5 mm, long cannulated | HXX | Screwdriver | 1 | PRECICE® Instruments |
22 | 00812258029128 | LKL2-000 | LKL2-000 | Orthopedic surgical instrument - Locking key | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
23 | 00812258029111 | LBD3-001 | LBD3-001 | Orthopedic surgical instrument - Straight hex driver, 6 mm | HXX | Screwdriver | 1 | PRECICE® Instruments |
24 | 00812258029104 | LBD2-001 | LBD2-001 | Orthopedic surgical instrument - Ball end hex driver, 6 mm | HXX | Screwdriver | 1 | PRECICE® Instruments |
25 | 00812258029098 | IMP3-000 | IMP3-000 | Orthopedic surgical instrument - Impactor, medium | HWA | Impactor | 1 | PRECICE® Instruments |
26 | 00812258029081 | ERM2-12.5 | ERM2-12.5 | Orthopedic surgical instrument - Cannulated entry drill, 12.5 mm | HTW | Bit, Drill | 1 | PRECICE® Instruments |
27 | 00812258029074 | DBT2-5.0 | DBT2-5.0 | Orthopedic surgical instrument - 5 mm calibrated drill, long | HTW | Bit, Drill | 1 | PRECICE® Instruments |
28 | 00812258029067 | DBT2-4.3 | DBT2-4.3 | Orthopedic surgical instrument - 4.3 mm calibrated drill, long | HTW | Bit, Drill | 1 | PRECICE® Instruments |
29 | 00812258029050 | DBS2-5.0 | DBS2-5.0 | Orthopedic surgical instrument - 5 mm drill bit, short | HTW | Bit, Drill | 1 | PRECICE® Instruments |
30 | 00812258029043 | DBS2-4.3 | DBS2-4.3 | Orthopedic surgical instrument - 4.3 mm drill bit, short | HTW | Bit, Drill | 1 | PRECICE® Instruments |
31 | 00812258029036 | DBS2-4.0 | DBS2-4.0 | Orthopedic surgical instrument - 4 mm drill bit, short | HTW | Bit, Drill | 1 | PRECICE® Instruments |
32 | 00812258029029 | DBS2-3.9 | DBS2-3.9 | Orthopedic surgical instrument - 3.9 mm drill bit, short | HTW | Bit, Drill | 1 | PRECICE® Instruments |
33 | 00812258029012 | DBS2-3.5 | DBS2-3.5 | Orthopedic surgical instrument - 3.5 mm drill bit, short | HTW | Bit, Drill | 1 | PRECICE® Instruments |
34 | 00812258029005 | DBS2-3.4 | DBS2-3.4 | Orthopedic surgical instrument - 3.4 mm drill bit, short | HTW | Bit, Drill | 1 | PRECICE® Instruments |
35 | 00812258028992 | CRS2-000 | CRS2-000 | Orthopedic surgical instrument - Screw capture rod, long | HXX | Screwdriver | 1 | PRECICE® Instruments |
36 | 00812258028985 | CED2-011 | CED2-011 | Orthopedic surgical instrument - Cannulated entry drill, 11mm | HTW | Bit, Drill | 1 | PRECICE® Instruments |
37 | 00812258028978 | CED2-008 | CED2-008 | Orthopedic surgical instrument - Cannulated entry drill, 8mm | HTW | Bit, Drill | 1 | PRECICE® Instruments |
38 | 00812258028961 | FXR2-000 | FXR2-000 | Orthopedic surgical instrument - Fracture reducer | HWN | Instrument, Compression | 1 | PRECICE® Instruments |
39 | 00812258028954 | SDG3-000 | SDG3-000 | Orthopedic surgical instrument - Screw Depth Gauge, 100mm | HTJ | Gauge, Depth | 1 | PRECICE® Instruments |
40 | 00812258028947 | HCB2-000 | HCB2-000 | Orthopedic surgical instrument - Honeycomb | LXH | Orthopedic Manual Surgical Instrument | 1 | PRECICE® Instruments |
41 | 00812258028930 | DGT2-001 | DGT2-001 | Orthopedic surgical instrument - Screw Gauge, Dip-Stick | HTJ | Gauge, Depth | 1 | PRECICE® Instruments |
42 | 00812258028923 | AWL2-010 | AWL2-010 | Orthopedic surgical instrument - Cannulated Awl | HWJ | Awl | 1 | PRECICE® Instruments |
43 | 00812258028916 | LBT2-001 | LBT2-001 | Orthopedic surgical instrument - Locking Bolt, Short | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
44 | 00812258028909 | LBT2-000 | LBT2-000 | Orthopedic surgical instrument - Locking Bolt, Long | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
45 | 00812258028893 | PGH1-001 | PGH1-001 | Orthopedic surgical instrument - Targeting Jig Handle, Short | LXH | Orthopedic Manual Surgical Instrument | 1 | PRECICE® Instruments |
46 | 00812258028886 | PGH1-000 | PGH1-000 | Orthopedic surgical instrument - Targeting Jig Handle, Long | LXH | Orthopedic Manual Surgical Instrument | 1 | PRECICE® Instruments |
47 | 00812258028879 | PGA1-004 | PGA1-004 | Orthopedic surgical instrument - Targeting Arm Universal Femur, Short | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
48 | 00812258028862 | PGA1-003 | PGA1-003 | Orthopedic surgical instrument - Targeting Arm Troch Femur, Short | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
49 | 00812258028855 | PGA1-002 | PGA1-002 | Orthopedic surgical instrument - Targeting Arm Tibia, UNYTE/Short | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Instruments |
50 | 00812258028282 | P10.7-50P175 | P10.7-50P175 | Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur, 10° Bend, 10. Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur, 10° Bend, 10.7 mm Diameter, 175 mm | HSB | Rod, Fixation, Intramedullary And Accessories | 2 | PRECICE® Intramedullary Limb Lengthening System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817662026022 | 1 | 1022-02 | SureMAX-SA Sterilization Tray — Base | SureMAX-SA | ADDITIVE IMPLANTS, LLC |
2 | 00817662026015 | 1 | 1022-01 | SureMAX-SA Sterlization Tray — Lid | SureMAX-SA | ADDITIVE IMPLANTS, LLC |
3 | 00817662024578 | 1 | Cervical Mallet | SureMAX | ADDITIVE IMPLANTS, LLC | |
4 | 00817662021720 | 1 | Closed Container | SureMAX | ADDITIVE IMPLANTS, LLC | |
5 | 00817662021713 | 1 | SureMAX-X Hyperlordotic Trial Caddie | SureMAX | ADDITIVE IMPLANTS, LLC | |
6 | 00817662021706 | 1 | Tray Assembly | SureMAX | ADDITIVE IMPLANTS, LLC | |
7 | 00817662021690 | 1 | Cervical Wedge Distractor Caddie | SureMAX | ADDITIVE IMPLANTS, LLC | |
8 | 00817662021683 | 1 | Cervical Rasp Caddie | SureMAX | ADDITIVE IMPLANTS, LLC | |
9 | 00817662021676 | 1 | SureMAX-X Lordotic Trial Caddie | SureMAX | ADDITIVE IMPLANTS, LLC | |
10 | 00817662021669 | 1 | SureMAX Lordotic Trial Caddie | SureMAX | ADDITIVE IMPLANTS, LLC | |
11 | 00817662021652 | 1 | SureMAX Hyperlordotic Trial Caddie | SureMAX | ADDITIVE IMPLANTS, LLC | |
12 | 00817662021645 | 1 | Cervical Interbody Sterilization Tray, Lid | SureMAX | ADDITIVE IMPLANTS, LLC | |
13 | 00817662021638 | 1 | Cervical Interbody Sterilization Tray, Base | SureMAX | ADDITIVE IMPLANTS, LLC | |
14 | 00817662020723 | 1 | Cervical Interbody Sterilization Tray Assembly | SureMAX | ADDITIVE IMPLANTS, LLC | |
15 | 00816744027193 | NN-7019 | Sterilization Tray | NICO BrainPath | NICO CORPORATION | |
16 | 00816519020763 | NRG-SP275/10 | IQ Dental Self Seal Sterilization Pouches 2.75X10 Box/200 | IQ Dental | IQ DENTAL SUPPLY LLC | |
17 | 00816519020756 | NRG-SP35/65 | IQ Dental Self Seal Sterilization Pouches 3.5X6.5 Box/200 | IQ Dental | IQ DENTAL SUPPLY LLC | |
18 | 00816519020749 | NRG-SP525/10 | IQ Dental Self Seal Sterilization Pouches 5.25X10 Box/200 | IQ Dental | IQ DENTAL SUPPLY LLC | |
19 | 00816519020732 | NRG-SP35/9 | IQ Dental Self Seal Sterilization Pouches 3.5X9 Box/200 | IQ Dental | IQ DENTAL SUPPLY LLC | |
20 | 00815878021053 | 72720843 | Burkhart Sterile Pouches 7-1/2" x 13" (200) | BURKHART DENTAL SUPPLY CO., THE | ||
21 | 00815878020193 | 72720010 | Burkhart Sterile Pouches 2-1/4"X4" 200/pkg | BURKHART DENTAL SUPPLY CO., THE | ||
22 | 00815878020186 | 72720005 | Burkhart Sterile Pouches 3-1/2"X5-1/4" 200/pkg | BURKHART DENTAL SUPPLY CO., THE | ||
23 | 00815878020179 | 72720006 | Burkhart Sterile Pouches 2-3/4"X10" 200/pkg | BURKHART DENTAL SUPPLY CO., THE | ||
24 | 00815878020162 | 72720007 | Burkhart Sterile Pouches 3-1/2"/x10" 200/pkg | BURKHART DENTAL SUPPLY CO., THE | ||
25 | 00815878020155 | 72720008 | Burkhart Sterile Pouches 3-1/2X"10" 500/pkg | BURKHART DENTAL SUPPLY CO., THE | ||
26 | 00815878020148 | 72720009 | Burkhart Sterile Pouches 5-1/4"X10" 200/pkg | BURKHART DENTAL SUPPLY CO., THE | ||
27 | 00815878020131 | 72720662 | Burkhart Select Multivariable Sterilization Pouch 3-1/2 x 9 (200) | BURKHART DENTAL SUPPLY CO., THE | ||
28 | 00815878020124 | 72720663 | Burkhart Select Multivariable Sterilezation Pouch 3 1/2 x 5 1/4 (200) | BURKHART DENTAL SUPPLY CO., THE | ||
29 | 00815878020117 | 72720661 | Burkhart Select Multivariable Sterilization Pouch 2 3/4 X 9 (200) | BURKHART DENTAL SUPPLY CO., THE | ||
30 | 00815878020100 | 72720660 | Burkhart Select Multivariable Sterilization Pouch 5 1/4X10 (200) | BURKHART DENTAL SUPPLY CO., THE | ||
31 | 00815842023175 | 1535-IMC | Sterilization Pouch, SS, 12" x 15" | IMCO | INDEPENDENT MEDICAL CO-OP, INC. | |
32 | 00815842023144 | 1525-IMC | Sterilization Pouch, SS, 5 1/4" x 10" | IMCO | INDEPENDENT MEDICAL CO-OP, INC. | |
33 | 00815842023137 | 1520-IMC | Sterilization Pouch, SS, 3 1/2" x 9" | IMCO | INDEPENDENT MEDICAL CO-OP, INC. | |
34 | 00815842023120 | 1510-IMC | Sterilization Pouch, SS, 7 1/2" x 13" | IMCO | INDEPENDENT MEDICAL CO-OP, INC. | |
35 | 00815842023113 | 1505-IMC | Sterilization Pouch, SS, 3 1/2"x 6 1/2" | IMCO | INDEPENDENT MEDICAL CO-OP, INC. | |
36 | 00815432029051 | MiniBunion Non-sterile Instrument Case | 280020 | The CrossRoads Tray System is used in healthcare facilities to store and organiz The CrossRoads Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The CrossRoads Tray System are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the worst-case CrossRoads Tray System included surgical instruments such as drills, inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Tray System is validated for a maximum load of 8.5 lbs (tray and instruments). Method Steam Sterilization (Moist Heat Sterilization) Cycle PrevacuumTemperature 270 F (132 C)Exposure time 4 minutesDrying time 20 minutesThe tray is 20.60 length x 9.80 width x 2.00 depth (inches). | CrossRoads Tray System | CROSSROADS EXTREMITY SYSTEMS |
37 | 00815432028924 | CrossRoads Tray System | 280600 | The CrossRoads Tray System is used in healthcare facilities to store and organiz The CrossRoads Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The CrossRoads Tray System are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the worst-case CrossRoads Tray System included surgical instruments such as drills, inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Tray System is validated for a maximum load of 8.5 lbs (tray and instruments). Method Steam Sterilization (Moist Heat Sterilization) Cycle PrevacuumTemperature 270 F (132 C)Exposure time 4 minutesDrying time 20 minutesThe tray is 20.60 length x 9.80 width x 2.00 depth (inches). | CrossRoads Tray System | CROSSROADS EXTREMITY SYSTEMS |
38 | 00814932020056 | IPN916268 | UL-PKTRAY | UROLIFT PROCEDURE KIT STERILIZATION TRAY | UROLIFT | TELEFLEX INCORPORATED |
39 | 00814334022054 | 8585032 | 8585032 | UROLOGY TRAY METAL reusable | NA | RICHARD WOLF GMBH |
40 | 00814334022047 | 8585030 | 8585030 | CYSTOSCOPY TRAY METAL reusable | NA | RICHARD WOLF GMBH |
41 | 00814334022030 | 88090001 | 88090001 | LUMBAR SPINE SURGERY TRAY METAL | NA | RICHARD WOLF GMBH |
42 | 00814334021682 | 88090009 | 88090009 | SPINE SURGERY TRAY STENOSIS METAL tray, reprocessing, for spinal stenosis instruments | NA | RICHARD WOLF GMBH |
43 | 00814334021675 | 880900016 | 880900016 | INSERT METAL | NA | RICHARD WOLF GMBH |
44 | 00814334021668 | 880900015 | 880900015 | UNIVERSAL TRAY METAL | NA | RICHARD WOLF GMBH |
45 | 00814334021651 | 880900012 | 880900012 | ENDOCAM TRAY PLASTIC | NA | RICHARD WOLF GMBH |
46 | 00814334021545 | 8585038 | 8585038 | TRAY FOR SMALL ANATOMY METAL reusable | NA | RICHARD WOLF GMBH |
47 | 00814334021538 | 8585035 | 8585035 | URO FLEX ENDOSCOPE TRAY PLASTIC reusable | NA | RICHARD WOLF GMBH |
48 | 00814334021521 | 85850302 | 85850302 | FLEX ENDOSCOPE TRAY METAL | NA | RICHARD WOLF GMBH |
49 | 00814334021514 | 8585012 | 8585012 | LONG LAPAROSCOPY TRAY METAL reusable | NA | RICHARD WOLF GMBH |
50 | 00814334021507 | 8585010 | 8585010 | LAPAROSCOPY TRAY METAL reusable | NA | RICHARD WOLF GMBH |