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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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Atlas Pro Driver Collet Attachment Hex - 00862377000171

No Description
PRO-DEX, INC.
APD-CA-001-1
In Commercial Distribution

  • 00862377000171 ()


  • Screwing power tool attachment

Atlas Pro Driver - 00862377000164

No Description
PRO-DEX, INC.
APD-1000-1
In Commercial Distribution

  • 00862377000164 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

KLS MARTIN SURGICAL DRIVER - 00862377000133

No Description
PRO-DEX, INC.
KLS-SD-1000
In Commercial Distribution

  • 00862377000133 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

MatrixPRO Driver Battery Pack, Sterile - 00862377000119

No Description
PRO-DEX, INC.
05.000.021S
In Commercial Distribution

  • 00862377000119 ()
  • 10862377000116 ()
  • 20862377000113 ()


  • Disposable battery pack

MatrixPRO driver Handpiece - 00862377000102

No Description
PRO-DEX, INC.
05.000.020
In Commercial Distribution

  • 00862377000102 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Aptima Unisex Specimen Collection Swab - 00862255000347

The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD215
In Commercial Distribution

  • 00862255000347 ()
CD215

  • General-purpose absorbent tip applicator/swab, single-use

MML Specimen Collection Swab - 00862255000330

The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD650
In Commercial Distribution

  • 00862255000330 ()
CD650

  • General-purpose absorbent tip applicator/swab, single-use

MML Specimen Collection Swab - 00862255000323

The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device. Note: MML’s customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customer’s collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customer’s specific collection kit.
Mml Diagnostics Packaging, Inc.
CD651
In Commercial Distribution

  • 00862255000323 ()
CD651

  • General-purpose absorbent tip applicator/swab, single-use

Atlas Pro Driver Sterilization Case - 00860540000294

No Description
PRO-DEX, INC.
APD-SC-001
In Commercial Distribution

  • 00860540000294 ()


  • Device sterilization/disinfection container, reusable

MatrixPRO Driver Loaner - 00860540000225

No Description
PRO-DEX, INC.
05.000.020LN
In Commercial Distribution

  • 00860540000225 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

T8 Driver Accessory Pack - 00857676008775

No Description
Eca Medical Instruments
1005
In Commercial Distribution

  • 00857676008775 ()


  • Cannulated surgical drill bit, single-use

3.0MM Drill Accessory Pack - 00857676008768

No Description
Eca Medical Instruments
1004-003
In Commercial Distribution

  • 00857676008768 ()


  • Cannulated surgical drill bit, single-use

2.7MM Drill Accessory Pack - 00857676008751

No Description
Eca Medical Instruments
1004-002
In Commercial Distribution

  • 00857676008751 ()


  • Cannulated surgical drill bit, single-use

2.0MM Drill Accessory Pack - 00857676008744

No Description
Eca Medical Instruments
1004-001
In Commercial Distribution

  • 00857676008744 ()


  • Cannulated surgical drill bit, single-use

TruFIX - 00857676008218

No Description
Eca Medical Instruments
Fixed Driver AO, Small Axial
In Commercial Distribution

  • 00857676008218 ()
806-004

  • Orthopaedic surgical procedure kit, non-medicated, single-use

TruFIX - 00857676008201

No Description
Eca Medical Instruments
Fixed Driver AO, Small Axial
In Commercial Distribution

  • 00857676008201 ()
806-003

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Arthrex - 00857676008195

No Description
Eca Medical Instruments
2.4 mm Volar Distal Radius Removal Driver
In Commercial Distribution

  • 00857676008195 ()
AR-8924VD-S

  • Surgical screwdriver, single-use

SynCardia Companion Driver Caddy Shipping Container - 00858000003237

No Description
SYNCARDIA SYSTEMS, LLC
297043-001
In Commercial Distribution

  • 00858000003237 ()


  • Ventricular prosthesis system, pneumatically-powered

SynCardia Companion Driver Shipping Container - 00858000003206

No Description
SYNCARDIA SYSTEMS, LLC
297032-100
In Commercial Distribution

  • 00858000003206 ()


  • Ventricular prosthesis system, pneumatically-powered

SynCardia Companion Driver Caddy - 00858000003145

No Description
SYNCARDIA SYSTEMS, LLC
397001-001
In Commercial Distribution

  • 00858000003145 ()


  • Ventricular prosthesis system, pneumatically-powered

SynCardia Freedom® Driver - 00858000003121

No Description
SYNCARDIA SYSTEMS, LLC
595000-001
In Commercial Distribution

  • 00858000003121 ()
  • 10858000003128 ()


  • Ventricular prosthesis system, pneumatically-powered

SynCardia Companion 2 Driver - 00858000003107

No Description
SYNCARDIA SYSTEMS, LLC
397002-001
In Commercial Distribution

  • 00858000003107 ()


  • Ventricular prosthesis system, pneumatically-powered

PONTiS Flexor Tendon Repair System - 00859210006025

PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3031
In Commercial Distribution

  • 00859210006025 ()

  • Length: 4.5 Millimeter
  • Outer Diameter: 3 Millimeter
400-3031

  • Tendon/ligament bone anchor, non-bioabsorbable

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

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 - 10889950014841

#1 Mead Immunity Mallet
HU-FRIEDY MFG. CO., LLC
MAL1
In Commercial Distribution

  • 10889950014841 ()
MAL1

  • Surgical mallet

Screwdriver HexaDrive - 05712149027408

Screwdriver HexaDrive. Consists of blade (DM DI 05712149027415) and handle (DM DI 057121490274225).
Oticon Medical AB
265497
In Commercial Distribution

  • 05712149027408 ()
  • 05712149027415 ()
265497

  • Surgical screwdriver, reusable

Elos Accurate® Scan Body 22 - 05712821009906

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-NBR60-1
In Commercial Distribution

  • 05712821009753 ()
  • 05712821009906 ()
SB-NBR60-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009890

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-NBR50-1
In Commercial Distribution

  • 05712821009746 ()
  • 05712821009890 ()
SB-NBR50-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009883

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-NBR43-1
In Commercial Distribution

  • 05712821009739 ()
  • 05712821009883 ()
SB-NBR43-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009876

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-NBR35-1
In Commercial Distribution

  • 05712821009722 ()
  • 05712821009876 ()
SB-NBR35-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009869

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-NBA60/SINGLE-1
In Commercial Distribution

  • 05712821009715 ()
  • 05712821009869 ()
SB-NBA60/SINGLE-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009852

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-NBA35/SINGLE-1
In Commercial Distribution

  • 05712821009708 ()
  • 05712821009852 ()
SB-NBA35/SINGLE-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009845

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-NBA30/SINGLE-1
In Commercial Distribution

  • 05712821009692 ()
  • 05712821009845 ()
SB-NBA30/SINGLE-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009838

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-MUA60-1
In Commercial Distribution

  • 05712821009685 ()
  • 05712821009838 ()
SB-MUA60-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009821

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-BRA51-1
In Commercial Distribution

  • 05712821009678 ()
  • 05712821009821 ()
SB-BRA51-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009814

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-BRA41-1
In Commercial Distribution

  • 05712821009661 ()
  • 05712821009814 ()
SB-BRA41-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009807

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-BRA35-1
In Commercial Distribution

  • 05712821009654 ()
  • 05712821009807 ()
SB-BRA35-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009791

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-ATE54-1
In Commercial Distribution

  • 05712821009647 ()
  • 05712821009791 ()
SB-ATE54-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009784

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-ATE48-1
In Commercial Distribution

  • 05712821009630 ()
  • 05712821009784 ()
SB-ATE48-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009777

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-ATE42-1
In Commercial Distribution

  • 05712821009623 ()
  • 05712821009777 ()
SB-ATE42-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821009760

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-ATE30-1
In Commercial Distribution

  • 05712821009616 ()
  • 05712821009760 ()
SB-ATE30-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 Driver / Medium - 05712821009548

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
SBD-M-1
In Commercial Distribution

  • 05712821009531 ()
  • 05712821009548 ()
SBD-M-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821008497

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-DAN35-1
In Commercial Distribution

  • 05712821008459 ()
  • 05712821008497 ()
SB-DAN35-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821008480

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-ATE36-1
In Commercial Distribution

  • 05712821008435 ()
  • 05712821008480 ()
SB-ATE36-1

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body 22 - 05712821008473

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-MUA45-1
In Commercial Distribution

  • 05712821008442 ()
  • 05712821008473 ()
SB-MUA45-1

  • Dental implant suprastructure, temporary, preformed, reusable
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