No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10381780177050 | 310-381 | DIETHRICH BYPASS CASE | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® | |
2 | 00381780169317 | 286-106 | Disposable Scoville Bayonet Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
3 | 00381780176988 | 286-112 | Disposable Bipolar Cord | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
4 | 00381780169355 | 286-111 | Disposable Hardy Bayonet Non-Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
5 | 00381780169348 | 286-110 | Disposable Hardy Bayonet Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
6 | 00381780169331 | 286-109 | Disposable Hardy Bayonet Non-Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
7 | 00381780169324 | 286-107 | Disposable Scoville Bayonet Non-Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
8 | 00381780169300 | 286-105 | Disposable Cushing Bayonet Non-Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
9 | 00381780169294 | 286-104 | Disposable Cushing Bayonet Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
10 | 00381780169287 | 286-103 | Disposable Adson Non-Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
11 | 00381780169270 | 286-101 | Disposable Jewelers Non-Insulated Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
12 | 00381780165845 | 286-102 | Disposable Adson Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
13 | 00381780165838 | 286-100 | Disposable Jewelers Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
14 | 00381780024982 | 286-108 | Disposable Hardy Bayonet Insulated Bipolar Forceps | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Integra® Jarit® | ||
15 | 10381780527527 | 117360A | 117-360A | Iodine Cup, 6 Oz. | KYW | CONTAINER, LIQUID MEDICATION, GRADUATED | 1 | Integra® Jarit® |
16 | 10381780527596 | 117392A | 117-392A | Emesis Basin, 26 Oz. | FNY | BASIN, EMESIS | 1 | Integra® Jarit® |
17 | 10381780527589 | 117391A | 117-391A | Emesis Basin, 12 Oz. | FNY | BASIN, EMESIS | 1 | Integra® Jarit® |
18 | 10381780527572 | 117390A | 117-390A | Emesis Basin, 10 Oz. | FNY | BASIN, EMESIS | 1 | Integra® Jarit® |
19 | 10381780527541 | 117370A | 117-370A | Graduated Measure, 32 Oz. | KYW | CONTAINER, LIQUID MEDICATION, GRADUATED | 1 | Integra® Jarit® |
20 | 10381780527534 | 117365A | 117-365A | Medicine Cup, Graduated, 2 Oz. | KYW | CONTAINER, LIQUID MEDICATION, GRADUATED | 1 | Integra® Jarit® |
21 | 10381780527510 | 117199A | 117-199A | Deep Perforated Instrument Tray, 17-3/8" x 12-5/8" x 2-1/2" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
22 | 10381780527503 | 117198A | 117-198A | Deep Perforated Instrument Tray, 15" x 11-1/4" x 2-1/2" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
23 | 10381780527497 | 117196A | 117-196A | Deep Perforated Instrument Tray, 12-3/4" x 10-1/2" x 2-1/2" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
24 | 10381780527480 | 117194A | 117-194A | Deep Perforated Instrument Tray, 12" x 7-3/4" x 2-1/2" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
25 | 10381780527473 | 117192A | 117-192A | Deep Perforated Instrument Tray, 10-3/8" x 6-3/4" x 1-7/8" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
26 | 10381780527466 | 117190A | 117-190A | Deep Perforated Instrument Tray, 8-3/4" x 5" x 1-3/4" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
27 | 10381780527459 | 117168A | 117-168A | Mayo Tray, Perforated, 19-1/4" x 12-3/4" x 3/4" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
28 | 10381780527442 | 117166A | 117-166A | Mayo Tray, Perforated, 17"x 11-3/4" x 3/4" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
29 | 10381780527435 | 117164A | 117-164A | Mayo Tray, Perforated, 15-1/4" x 10-5/8" x 3/4" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
30 | 10381780527428 | 117162A | 117-162A | Mayo Tray, Perforated, 13-3/4" x 10" x 3/4" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
31 | 10381780527411 | 117160A | 117-160A | Mayo Tray, Perforated, 10"x 6-1/2" x 3/4" | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Integra® Jarit® |
32 | 10381780524663 | NS0602 | NS0602 | Cylindrical, Large Rickham Reservoir, Programmable in steps of 10mm | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
33 | 10381780524557 | NS0589 | NS0589 | Cylindrical Valve, Unitized Large RICKHAM® Reservoir, Metal Base, Barium Distal Cylindrical Valve, Unitized Large RICKHAM® Reservoir, Metal Base, Barium Distal Catheter with Slits, 120cm, 30mm H2O to 200mm H2O, Programmable in steps of 10mm | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
34 | 10381780523994 | NS0310A | NS0310A | Unitized RICKHAM® Reservoir, 2cm Arm, Unitized Clear Distal Catheter, Barium Str Unitized RICKHAM® Reservoir, 2cm Arm, Unitized Clear Distal Catheter, Barium Stripe 120cm, Operating Pressure 30mm H2O to 200mm, programmable in steps of 10mm | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
35 | 10381780523987 | NS0308 | NS0308 | Unitized RICKHAM® Reservoir with SIPHONGUARD® Device, Unitized Clear Distal Cath Unitized RICKHAM® Reservoir with SIPHONGUARD® Device, Unitized Clear Distal Catheter, Barium Stripe 120cm, Operating Pressure 30mm | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® SIPHONGUARD® |
36 | 10381780519898 | 823855 | 82-3855 | Programmable Valve with Unitized RICKHAM® Reservoir and Non-Unitized Distal Catheter | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
37 | 10381780519881 | 823854 | 82-3854 | In-Line Valve SIPHONGUARD® Device, .060" Platform and Unitized Distal Catheter | JXG | Shunt, central nervous system and components | 2 | HAKIM® SIPHONGUARD® HOLTER |
38 | 10381780519874 | 823853 | 82-3853 | with Unitized RICKHAM® Reservoir and Distal Catheter with Slits 85cm | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
39 | 10381780519867 | 823852 | 82-3852 | Programmable Valve with Unitized Large RICKHAM® Reservoir and Non-Unitized Distal Catheter | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
40 | 10381780519850 | 823851 | 82-3851 | with Unitized RICKHAM® Reservoir and Unitized Distal Catheter 120cm | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
41 | 10381780519195 | 823116 | 82-3116 | Micro Valve with RICKHAM® Reservoir | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
42 | 10381780519348 | 823192R | 82-3192R | System Contents: One Each: Program Unit, Transmitter Unit, Power Cord, Ultrasoun System Contents: One Each: Program Unit, Transmitter Unit, Power Cord, Ultrasound Gel, Instructions for Use, and Carrying Case | JXG | Shunt, central nervous system and components | 2 | CODMAN® VPV® |
43 | 10381780519164 | 823113 | 82-3113 | Micro Valve with RICKHAM Reservoir and Unitized Distal Catheter | JXG | Shunt, central nervous system and components | 2 | HAKIM® RICKHAM® |
44 | 10381780517764 | 821619 | 82-1619 | SELKER Reservoir Large With Nylon Base for 4mm Burr Hole 18.5mm | JXG | Shunt, central nervous system and components | 2 | CODMAN® HOLTER® |
45 | 10381780517757 | 821618 | 82-1618 | SELKER Reservoir Standard With Nylon Base for 4mm Burr Hole 14mm | JXG | Shunt, central nervous system and components | 2 | CODMAN® HOLTER® |
46 | 10381780517405 | 8155100S | 8155100S | AHT Bipolar Forceps Tips TIP STYLE Low Profile | GEI | Electrosurgical, cutting & coagulation & accessories | 2 | ISOCOOL® |
47 | 10381780517399 | 8155050S | 8155050S | AHT Bipolar Forceps Tips TIP STYLE Low Profile | GEI | Electrosurgical, cutting & coagulation & accessories | 2 | ISOCOOL® |
48 | 10381780517382 | 8155025S | 8155025S | AHT Bipolar Forceps Tips TIP STYLE Low Profile | GEI | Electrosurgical, cutting & coagulation & accessories | 2 | ISOCOOL® |
49 | 10381780517375 | 8145200S | 8145200S | AHT Bipolar Forceps Tips TIP STYLE Low Profile | GEI | Electrosurgical, cutting & coagulation & accessories | 2 | ISOCOOL® |
50 | 10381780517368 | 8145100S | 8145100S | AHT Bipolar Forceps Tips TIP STYLE Low Profile | GEI | Electrosurgical, cutting & coagulation & accessories | 2 | ISOCOOL® |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M963IFS250 | IFS2.5 | IFS2.5 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 3ea K-wires with sharps protection, and 1ea Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
2 | M9632585S30 | 2585S3 | 2585S3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") double trocar k-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
3 | M9632585S20 | 2585S2 | 2585S2 | 'Product received FDA 510(k) clearance for: small bone fixation, reconstruction 'Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in place with a locking pin; 1ea 1.1mm (0.045") Double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
4 | M9632585L30 | 2585L3 | 2585L3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") double trocar k-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
5 | M9632565S30 | 2565S3 | 2565S3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") Double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
6 | M9632565L30 | 2565L3 | 2565L3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin, 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
7 | M9632265L30 | 2265L3 | 2265L3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of findgers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol Intramedullary Fixation Scaffold (SuperScaffold™) implant held in place by use of a locking pin; 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.2mm Drill Bit with integral handle for manual use. | SuperScaffold™ | METRIC MEDICAL DEVICES, INC. |
8 | M7557923181 | gS 79.2316 | gS 79.2316 | K-Wire D. Trocar 6" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
9 | M7557923161 | gS 79.2318 | gS 79.2318 | K-Wire D. Trocar 6" 1.8mm [.070"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
10 | M7557923160 | gS 79.2316 | gS 79.2316 | K-Wire D. Trocar 6" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
11 | M7557923151 | gS 79.2315 | gS 79.2315 | K-Wire D. Trocar 6" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
12 | M7557923150 | gS 79.2315 | gS 79.2315 | K-Wire D. Trocar 6" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
13 | M7557923121 | gS 79.2312 | gS 79.2312 | K-Wire D. Trocar 6" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
14 | M7557923120 | gS 79.2312 | gS 79.2312 | K-Wire D. Trocar 6" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
15 | M7557923101 | gS 79.2310 | gS 79.2310 | K-Wire D. Trocar 6" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
16 | M7557923100 | gS 79.2310 | gS 79.2310 | K-Wire D. Trocar 6" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
17 | M7557923061 | gS 79.2306 | gS 79.2306 | K-Wire D. Trocar 6" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
18 | M7557923060 | gS 79.2306 | gS 79.2306 | K-Wire D. Trocar 6" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
19 | M7557921181 | gS 79.2118 | gS 79.2118 | K-Wire D. Trocar 4" 1.8mm [.070"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
20 | M7557921180 | gS 79.2118 | gS 79.2118 | K-Wire D. Trocar 4" 1.8mm [.070"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
21 | M7557921161 | gS 79.2116 | gS 79.2116 | K-Wire D. Trocar 4" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
22 | M7557921160 | gS 79.2116 | gS 79.2116 | K-Wire D. Trocar 4" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
23 | M7557921151 | gS 79.2115 | gS 79.2115 | K-Wire D. Trocar 4" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
24 | M7557921150 | gS 79.2115 | gS 79.2115 | K-Wire D. Trocar 4" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
25 | M7557921121 | gS 79.2112 | gS 79.2112 | K-Wire D. Trocar 4" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
26 | M7557921120 | gS 79.2112 | gS 79.2112 | K-Wire D. Trocar 4" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
27 | M7557921101 | gS 79.2110 | gS 79.2110 | K-Wire D. Trocar 4" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
28 | M7557921100 | gS 79.2110 | gS 79.2110 | K-Wire D. Trocar 4" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
29 | M7557921061 | gS 79.2106 | gS 79.2106 | K-Wire D. Trocar 4" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
30 | M7557921060 | gS 79.2106 | gS 79.2106 | K-Wire D. Trocar 4" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
31 | M7557884801 | gS 78.8480 | Stein. Pin D. Diam Thr. 9" 4.5mm [.177"] pkg/6 | gSource | GSOURCE LLC | |
32 | M7557884800 | gS 78.8480 | gS 78.8480 | Stein. Pin D. Diam Thr. 9" 4.5mm [.177"] pkg/6 | gSource | GSOURCE LLC |
33 | M7557883300 | gS 78.8330 | gS 78.8330 | Stein. Pin D. Diam Thr. 9" 2.4mm [.094"] pkg/6 | gSource | GSOURCE LLC |
34 | M7557883001 | gS 78.8300 | Stein. Pin D. Diam Thr. 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC | |
35 | M7557883000 | gS 78.8300 | gS 78.8300 | Stein. Pin D. Diam Thr. 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC |
36 | M7557879401 | gS 78.7940 | Stein. Pin S. Troc Rd 12" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC | |
37 | M7557879400 | gS 78.7940 | gS 78.7940 | Stein. Pin S. Troc Rd 12" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC |
38 | M7557878001 | gS 78.7800 | Stein. Pin S. Troc Rd 12" 3.2mm [.126"] pkg/6 | gSource | GSOURCE LLC | |
39 | M7557878000 | gS 78.7800 | gS 78.7800 | Stein. Pin S. Troc Rd 12" 3.2mm [.126"] pkg/6 | gSource | GSOURCE LLC |
40 | M7557877820 | gS 78.7782 | gS 78.7782 | Stein. Pin S. Diam Rd 9" 4.5mm [.177"] pkg/6 | gSource | GSOURCE LLC |
41 | M7557877801 | gS 78.7780 | Stein. Pin S. Diam Rd 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC | |
42 | M7557877800 | gS 78.7780 | gS 78.7780 | Stein. Pin S. Diam Rd 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC |
43 | M7557877501 | gS 78.7750 | Stein. Pin S. Diam Rd 9" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC | |
44 | M7557877500 | gS 78.7750 | gS 78.7750 | Stein. Pin S. Diam Rd 9" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC |
45 | M7557877201 | gS 78.7720 | Stein. Pin S. Diam Rd 9" 3.5mm [.138"] pkg/6 | gSource | GSOURCE LLC | |
46 | M7557877200 | gS 78.7720 | gS 78.7720 | Stein. Pin S. Diam Rd 9" 3.5mm [.138"] pkg/6 | gSource | GSOURCE LLC |
47 | M7557876901 | gS 78.7690 | K-Wire S. Trocar 4" 1.4mm [.054"] pkg/6 | gSource | GSOURCE LLC | |
48 | M7557876900 | gS 78.7690 | gS 78.7690 | K-Wire S. Trocar 4" 1.4mm [.054"] pkg/6 | gSource | GSOURCE LLC |
49 | M7557876601 | gS 78.7660 | Stein. Pin S. Diam Rd 9" 2.8mm [.110"] pkg/6 | gSource | GSOURCE LLC | |
50 | M7557876600 | gS 78.7660 | gS 78.7660 | Stein. Pin S. Diam Rd 9" 2.8mm [.110"] pkg/6 | gSource | GSOURCE LLC |