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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology - 00191375025887

Interbody Fusion Device 16 Degree Standard 17mm
TITAN SPINE, LLC
2316-0117-N
Not in Commercial Distribution

  • 00191375025887 ()

  • width(MLxAP), 32 x 21, mm
  • Angle: 16 degree
  • Depth: 21 Millimeter
  • Width: 32 Millimeter
  • Height: 17 Millimeter
  • Lordotic Angle 16 Deg
2316-0117-N

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology - 00191375025870

Interbody Fusion Device 16 Degree Standard 16mm
MEDTRONIC SOFAMOR DANEK, INC.
2316-0116-N
In Commercial Distribution

  • 00191375025870 ()

  • Depth: 21 Millimeter
  • Width: 32 Millimeter
  • Angle: 16 degree
  • width(MLxAP), 32 x 21, mm
  • Height: 16 Millimeter
  • Lordotic Angle 16 Deg


  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology - 00191375025863

Interbody Fusion Device 16 Degree Standard 15mm
TITAN SPINE, LLC
2316-0115-N
Not in Commercial Distribution

  • 00191375025863 ()

  • width(MLxAP), 32 x 21, mm
  • Angle: 16 degree
  • Width: 32 Millimeter
  • Depth: 21 Millimeter
  • Height: 15 Millimeter
  • Lordotic Angle 16 Deg
2316-0115-N

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology - 00191375025856

Interbody Fusion Device 16 Degree Standard 14mm
MEDTRONIC SOFAMOR DANEK, INC.
2316-0114-N
In Commercial Distribution

  • 00191375025856 ()

  • Angle: 16 degree
  • Width: 32 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Depth: 21 Millimeter
  • Height: 14 Millimeter
  • Lordotic Angle 16 Deg


  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology - 00191375025849

Interbody Fusion Device 16 Degree Standard 13mm
TITAN SPINE, LLC
2316-0113-N
Not in Commercial Distribution

  • 00191375025849 ()

  • Width: 32 Millimeter
  • Depth: 21 Millimeter
  • Angle: 16 degree
  • width(MLxAP), 32 x 21, mm
  • Height: 13 Millimeter
  • Lordotic Angle 16 Deg
2316-0113-N

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology - 00191375025832

Interbody Fusion Device 16 Degree Standard 12mm
MEDTRONIC SOFAMOR DANEK, INC.
2316-0112-N
In Commercial Distribution

  • 00191375025832 ()

  • Depth: 21 Millimeter
  • Angle: 16 degree
  • Width: 32 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Height: 12 Millimeter
  • Lordotic Angle 16 Deg


  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology - 00191375025825

Interbody Fusion Device 16 Degree Standard 11mm
TITAN SPINE, LLC
2316-0111-N
Not in Commercial Distribution

  • 00191375025825 ()

  • Width: 32 Millimeter
  • Depth: 21 Millimeter
  • Angle: 16 degree
  • width(MLxAP), 32 x 21, mm
  • Height: 11 Millimeter
  • Lordotic Angle 16 Deg
2316-0111-N

  • Metallic spinal interbody fusion cage

OT EQUATOR - OT BRIDGE - 08059224106649

DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection and the thread are compatible with the specific implant; available in different cuff heights. Retentive caps of different retentive forces, metal housing for the caps and protective disc.
RHEIN 83 SRL
OT EQUATOR SCREW VENT h.7 c/TAS,
In Commercial Distribution

130CV7T

  • Dental implant suprastructure, permanent, preformed

OT EQUATOR - OT BRIDGE - 08059224137230

Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
OT EQUATOR SCREW VENT h.5 c/TAS,
In Commercial Distribution

130CV5T

  • Dental implant suprastructure, permanent, preformed

OT EQUATOR - OT BRIDGE - 08059224092720

DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection and the thread are compatible with the specific implant; available in different cuff heights. Retentive caps of different retentive forces, metal housing for the caps and protective disc.
RHEIN 83 SRL
OT EQUATOR SCREW VENT h.6 c/TAS,
In Commercial Distribution

  • 08059224092720 ()
130CV6T

  • Dental implant suprastructure, permanent, preformed

OT EQUATOR-OT BRIDGE - D821130CV7T0

Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
OT EQUATOR SCREW VENT h.7 c/TAS,
Not in Commercial Distribution

  • D821130CV7T0 ()
130CV7T

  • Surgical instrument handle, non-torque-limiting

OT EQUATOR-OT BRIDGE - D821130CV5T0

No Description
RHEIN 83 SRL
OT EQUATOR SCREW VENT h.5 c/TAS,
Not in Commercial Distribution

  • D821130CV5T0 ()
130CV5T

  • Surgical instrument handle, non-torque-limiting

SPHERO BLOCK NORMO - D821002BRK6RT0

Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/BLOCK NORMO BRANEMARK h.6 TiN c/TAS
Not in Commercial Distribution

  • D821002BRK6RT0 ()


  • Dental implant suprastructure, permanent, preformed

SPHERO BLOCK NORMO - 08059224009407

The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/BLOCK NORMO BRANEMARK h.6 TiN c/TAS
In Commercial Distribution

002BRK6RT

  • Dental implant suprastructure, permanent, preformed

OT EQUATOR TITANIUM ABUTMENT - 08059224087313

The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
OT EQUATOR ASTRA ST ø 4 h.5 c/TAS
In Commercial Distribution

  • 08059224087313 ()
130AS4NC5T

  • Dental implant suprastructure, permanent, preformed

SPHERO BLOCK NORMO - 08059224018522

Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/BLOCK NORMO CORE VENT h.4 TiN c/TAS
In Commercial Distribution

  • 08059224018522 ()
002CV4RT

  • Dental implant suprastructure, permanent, preformed

SPHERO BLOCK NORMO - 08059224188348

Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S.BLOCK N.BIO HORIZONS ø 3 h.7 TiN c/tas
In Commercial Distribution

  • 08059224188348 ()
002BH37RT

  • Dental implant suprastructure, permanent, preformed

SPHERO BLOCK MICRO - 08059224188324

The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPHERO BLOCK M. BLX RB-WB h.6 TiN c/tas
In Commercial Distribution

  • 08059224188324 ()
003BLX7R

  • Dental implant suprastructure, permanent, preformed

Dynesys - 00880304989368

Dynesys® TL Hex Driver
ZIMMER SPINE, INC.
07.00737.701
In Commercial Distribution

  • 00880304989368 ()
07.00737.701

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Screw Driver Bit T20 - 00688346002065

No Description
Laboratoires Bodycad Inc
027-207-100
In Commercial Distribution

  • 00688346002065 ()
027-207-100

  • Surgical screwdriver, reusable

Screw Driver Bit T15 - 00688346001044

No Description
Laboratoires Bodycad Inc
027-201-100
In Commercial Distribution

  • 00688346001044 ()
027-201-100

  • Surgical screwdriver, reusable

MIS Precision Chevron Bunion System - 00860005968800

The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile

EasyShift - 00860004936817

EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Seneca Devices, Inc.
EAS-42-Z
In Commercial Distribution

  • 00860004936817 ()


  • Bed mattress support platform, hydraulic
  • Intensive-care patient transport system, ventilatory support, neonatal

Assembly Required Distributors Inc. - 00860004575627

Doctor Stool Replacement Rubber Tip
Assembly Required Distributors Inc
CHM8908-01
In Commercial Distribution

  • 00860004575627 ()


  • Walking aid tip

AXIUS 8mm Needle Driver - Long - 00860004002147

No Description
FlexDex Surgical
8ND1L
In Commercial Distribution

  • 00860004002147 ()


  • Suturing needle holder, reusable

AXIUS 8mm Needle Driver - Medium - 00860004002130

No Description
FlexDex Surgical
8ND1M
In Commercial Distribution

  • 00860004002130 ()


  • Suturing needle holder, reusable

FlexDex Needle Driver - 00860004002109

No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use

Abiomed Breethe OXY-1 System - 00860001797947

Pump Driver Service Replacement Kit
Breethe, Inc.
001-0301-003
In Commercial Distribution

  • 00860001797947 ()
001-0301-003

  • Cardiopulmonary bypass system, non-roller type

Ponto - 05712149001026

Screwdriver hexagon
Oticon Medical AB
M50534
In Commercial Distribution

  • 05712149001026 ()
M50534

  • Surgical screwdriver, reusable

Ponto - 05712149000654

Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562).
Oticon Medical AB
M50437
In Commercial Distribution

  • 05712149000654 ()
  • 05712149024568 ()
M50437

  • Surgical screwdriver, reusable

Ponto - 05712149000586

Square fit connection, machine
Oticon Medical AB
M50386
In Commercial Distribution

  • 05712149000586 ()
M50386

  • Surgical screwdriver, reusable

Ponto - 05712149000562

Screwdriver, machine, 35mm
Oticon Medical AB
M50384
In Commercial Distribution

  • 05712149000562 ()
M50384

  • Surgical screwdriver, reusable

HU-FRIEDY - 10889950020668

Nylon Facing For #1 Mallet
HU-FRIEDY MFG. CO., LLC
PTNFM1
Not in Commercial Distribution

  • 10889950020668 ()
PTNFM1

  • Surgical mallet

Ponto - 05712149009909

Insertion indicator
Oticon Medical AB
M52366
Not in Commercial Distribution

  • 05712149009909 ()
M52366

  • Surgical screwdriver, reusable

Ponto - 05712149005895

Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution

  • 05712149005895 ()
M51695

  • Surgical screwdriver, reusable

TECHFIT - 00860007543494

Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543494 ()
GCLPFBC

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860007543487

Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543487 ()
GCLRFBC

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860007543470

Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543470 ()
GCLPBC

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860007543463

Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

  • Custom-made orthopaedic/craniofacial surgical guide

TECHFIT - 00860007543456

Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543456 ()
FFCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
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