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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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Elos Accurate® Scan Body 22 - 05712821010988

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-DBA40-1
In Commercial Distribution

  • 05712821010988 ()
  • 05712821010780 ()
SB-DBA40-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821010971

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-AUE33-1
In Commercial Distribution

  • 05712821010773 ()
  • 05712821010971 ()
SB-AUE33-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821010964

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-ATO45-1
In Commercial Distribution

  • 05712821010766 ()
  • 05712821010964 ()
SB-ATO45-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821010957

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-ATO35-1
In Commercial Distribution

  • 05712821010759 ()
  • 05712821010957 ()
SB-ATO35-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821010940

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
SB-ATO30-1
In Commercial Distribution

  • 05712821010742 ()
  • 05712821010940 ()
SB-ATO30-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821010681

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 13B-A
In Commercial Distribution

  • 05712821010643 ()
  • 05712821010681 ()
IO 13B-A

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821010674

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 13A-A
In Commercial Distribution

  • 05712821010636 ()
  • 05712821010674 ()
IO 13A-A

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821010667

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-B
In Commercial Distribution

  • 05712821010629 ()
  • 05712821010667 ()
IO 12A-B

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821010650

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-A
In Commercial Distribution

  • 05712821010612 ()
  • 05712821010650 ()
IO 12A-A

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Hexalobular Prosthetic Screw - 05712821010544

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-NGMM1610A-1
In Commercial Distribution

  • 05712821010544 ()
AS-NGMM1610A-1

  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821010537

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-HETM2008A-1
In Commercial Distribution

  • 05712821010537 ()
AS-HETM2008A-1

  • Dental prosthesis/implant abutment screw

Elos Accurate® Hexalobular Prosthetic Screw - 05712821010520

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Elos Medtech Pinol A/S
AS-HETM1610A-1
In Commercial Distribution

  • 05712821010520 ()
AS-HETM1610A-1

  • Dental prosthesis/implant abutment screw

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

TECHFIT - 00860007543449

Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide

Insurgical, Inc. - 00860007230066

2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution

  • 00860007230066 ()
9250022

  • Pin-driving power tool attachment

Insurgical, Inc. - 00860007230059

3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution

  • 00860007230059 ()
9250023

  • Pin-driving power tool attachment

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

HU-FRIEDY - 10889950007003

Nash/Taylor Crown Remover Hammer
HU-FRIEDY MFG. CO., LLC
CRH
In Commercial Distribution

  • 10889950007003 ()
CRH

  • Surgical mallet

Medtronic Reusable Instruments - 00673978154657

SCREWDRIVER X1198-019 MAS SHAFT 11 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X1198-019
In Commercial Distribution

  • 00673978154657 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978153773

AXIS/ORION SCREWDRIVER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X1196-002
In Commercial Distribution

  • 00673978153773 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978151786

5.5MM FIXED SCRW DRIVER M8 EXT
MEDTRONIC SOFAMOR DANEK, INC.
X1098-023
In Commercial Distribution

  • 00673978151786 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00673978151274

M10 DRIVER SHAFT, T30 DRIVE
MEDTRONIC SOFAMOR DANEK, INC.
X1097-044
In Commercial Distribution

  • 00673978151274 ()


  • Orthopaedic implant driver

ClearPoint - 00850359007584

SF M6 Bolt Driver
Clearpoint Neuro, Inc.
NGS-BD-M6
In Commercial Distribution

  • 00850359007584 ()
NGS-BD-M6

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551148784

SEEG ANCHOR BOLT DRIVER, 235MM LENGTH FOR 2.1MM DRILL
PMT CORPORATION
2103-204
In Commercial Distribution

  • 00650551148784 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551147503

SEEG DEPTH ANCHOR BOLT DRIVER WITH MEDIUM WELL SOCKET FOR 2.4MM DRILL
PMT CORPORATION
2103-144
In Commercial Distribution

  • 00650551147503 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551147480

BUSHING FOR 2.4MM DRIVER FOR NEUROMATE
PMT CORPORATION
2103-183
In Commercial Distribution

  • 00650551147480 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551146391

RULER, WITH SAME DIAMETER AS sEEG DRIVER, FOR 2.1MM DIAMETER DRILL BIT
PMT CORPORATION
2103-125
In Commercial Distribution

  • 00650551146391 ()
2103-125

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551137580

VERTEK BUSHING FOR 2.4MM DRILL/DRIVER W/THUMBSCREW
PMT CORPORATION
2103-154
In Commercial Distribution

  • 00650551137580 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551137573

VERTEK BUSHING FOR 2.1MM DRILL/DRIVER W/THUMBSCREW
PMT CORPORATION
2103-153
In Commercial Distribution

  • 00650551137573 ()


  • Neurological stereotactic surgery system

STEREOTACTIC - 00650551148821

BUSHING FOR LEKSELL LOWER GUIDE BUSHING FOR 2.4MM DRILL/DRIVER, 83MM LENGTH
PMT CORPORATION
2103-206
In Commercial Distribution

  • 00650551148821 ()


  • Neurological stereotactic surgery system

STEREOTACTIC - 00650551148623

BRAINLAB/VERTEK BUSHING FOR 2.4MM DRILL/DRIVER, 70MM LENGTH
PMT CORPORATION
2103-203
In Commercial Distribution

  • 00650551148623 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551148616

SEEG ANCHOR BOLT DRIVER, 235MM LENGTH FOR 2.4MM DRILL
PMT CORPORATION
2103-202
In Commercial Distribution

  • 00650551148616 ()


  • Neurological stereotactic surgery system

Thompson - 00851267006980

Hex Driver
THOMPSON SURGICAL INSTRUMENTS, INC.
10060020
In Commercial Distribution

  • 00851267006980 ()


  • Surgical retraction system, reusable

SAM Medical - 00850068519033

SAM IO Driver
ZIEN MEDICAL TECHNOLOGIES, INC.
IO700
In Commercial Distribution

  • 10850068519030 ()
  • 00850068519033 ()


  • Intraosseous-access handpiece, infusion, manual

Wheelhouse Medical Specials - 00850058050102

No Description
Wheelhouse Medical
WM01-0112
In Commercial Distribution

  • 00850058050102 ()


  • Surgical screwdriver, reusable

Wheelhouse Medical Specials - 00850058050072

No Description
Wheelhouse Medical
WM01-0086
In Commercial Distribution

  • 00850058050072 ()


  • Surgical screwdriver, reusable

FORWARD IO INFUSION KIT - 00850056748018

FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
INTEGRATED MEDCRAFT LLC
1011-23000CB
In Commercial Distribution

  • 00850056748018 ()


  • Intraosseous infusion kit

SI-RESTORE - 00850073363294

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300035
In Commercial Distribution

  • 00850073363294 ()


  • Surgical screwdriver, reusable

SI-RESTORE - 00850073363270

MALLET
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300031
In Commercial Distribution

  • 00850073363270 ()


  • Surgical mallet

SI-RESTORE - 00850073363218

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300017
In Commercial Distribution

  • 00850073363218 ()


  • Surgical screwdriver, reusable

EquiLOX Lumbar Expandable Cage - Square Cage Driver (AO connector) - 00850065741253

Square Cage Driver (AO connector)
CAPTIVA SPINE, INC.
CSE06-R-0500-86
In Commercial Distribution

  • 00850065741253 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver

EquiLOX Lumbar Expandable Cage - Slap Hammer (tuning fork style) - 00850065741239

Slap Hammer (tuning fork style)
CAPTIVA SPINE, INC.
CSE06-R-1000-29
In Commercial Distribution

  • 00850065741239 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Hammer power shaft - 00850065741055

Hammer power shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-26
In Commercial Distribution

  • 00850065741055 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Hammer connecting shaft - 00850065741048

Hammer connecting shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-28
In Commercial Distribution

  • 00850065741048 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Square Cage Driver - 00850065741031

Square Cage Driver
CAPTIVA SPINE, INC.
CSE06-R-0500-48
In Commercial Distribution

  • 00850065741031 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver
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