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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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Arthrex® - 00888867220010

T10 HEXALOBE SHAFT, SOLID, STRAIGHT
ARTHREX, INC.
AR-8950SD-10
In Commercial Distribution

  • 00888867220010 ()
AR-8950SD-10

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867220003

T8 HEXALOBE SHAFT, SOLID, STRAIGHT
ARTHREX, INC.
AR-8950SD-08
In Commercial Distribution

  • 00888867220003 ()
AR-8950SD-08

  • Cannulated surgical drill bit, single-use

Smileloc® BY RODO - 00816131023678

Smileclip Abutment Driver - Short
RODO MEDICAL, INC.
90.600
In Commercial Distribution

  • 00816131023678 ()


  • Surgical screwdriver, reusable

Smileloc® BY RODO - 00816131023432

Smileclip Abutment Driver - Medium
RODO MEDICAL, INC.
90.601
In Commercial Distribution

  • 00816131023432 ()
90.601

  • Surgical screwdriver, reusable

Smileloc® BY RODO - 00816131023173

Abutment Socket Driver - Short
RODO MEDICAL, INC.
90.003
In Commercial Distribution

  • 00816131023173 ()
90.003

  • Surgical screwdriver, reusable

Smileloc® BY RODO - 00816131023166

Abutment Socket Driver - Medium
RODO MEDICAL, INC.
90.002
In Commercial Distribution

  • 00816131023166 ()
90.002

  • Surgical screwdriver, reusable

Reprocessed 2.0mm Cannulated Hex Driver - B390HT11201

No Description
SURETEK MEDICAL
HT-1120
In Commercial Distribution

  • B390HT11201 ()


  • Fluted surgical drill bit, single-use

Reprocessed Driver Hex, Sterilemica, Screw System, 2.5mm - B39057S020251

No Description
SURETEK MEDICAL
57S02025
In Commercial Distribution

  • B39057S020251 ()


  • Drilling power tool attachment, basic

Reprocessed Driver Hex, Sterilemica, Screw System, 2.0mm - B39057S020201

No Description
SURETEK MEDICAL
57S02020
In Commercial Distribution

  • B39057S020201 ()


  • Drilling power tool attachment, basic

VerteLP Interbody Fusion Device - B387VLPBALLHEX0

VerteLP Angled Implant Inserter Ball-end Hex Driver
VGI MEDICAL, LLC
VLP-BALLHEX
In Commercial Distribution

  • B387VLPBALLHEX0 ()
VLPBALLHEX

  • Orthopaedic fixation implant alignment tool

Surgical Direct - B382SDM330500

Bone Mallet, 500g.
Surgical Direct, Inc.
SDM33050
In Commercial Distribution

  • B382SDM330500 ()
SDM33050

  • Surgical mallet

Surgical Direct - B382SDM188000

4.5mm Pointed Drill Guide
Surgical Direct, Inc.
SDM18800
In Commercial Distribution

  • B382SDM188000 ()
SDM18800

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM187000

Double Drill Sleeve 3.5mm/2.5mm
Surgical Direct, Inc.
SDM18700
In Commercial Distribution

  • B382SDM187000 ()
SDM18700

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM185140

Drill Sleeve Insert for 2.7/2.0mm
Surgical Direct, Inc.
SDM18514
In Commercial Distribution

  • B382SDM185140 ()
SDM18514

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM185130

1.5mm/1.1mm Double Drill Sleeve
Surgical Direct, Inc.
SDM18513
In Commercial Distribution

  • B382SDM185130 ()
SDM18513

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM185080

Drill Guide and Sleeve for 2.0mm
Surgical Direct, Inc.
SDM18508
In Commercial Distribution

  • B382SDM185080 ()
SDM18508

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM1850750

Neutral and Load Drill Guide 2.0mm, Drill Bit 1.5mm
Surgical Direct, Inc.
SDM185075
In Commercial Distribution

  • B382SDM1850750 ()
SDM185075

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM185070

Neutral and Load Drill Guide 2.7mm, Drill Bit 2.0mm
Surgical Direct, Inc.
SDM18507
In Commercial Distribution

  • B382SDM185070 ()
SDM18507

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM185060

Neutral and Load Drill Guide 2.5mm Drill Bit
Surgical Direct, Inc.
SDM18506
In Commercial Distribution

  • B382SDM185060 ()
SDM18506

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM185050

Neutral and Load Drill Guide 3.2mm / 4.5mm
Surgical Direct, Inc.
SDM18505
In Commercial Distribution

  • B382SDM185050 ()
SDM18505

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM185040

3.2 & 4.5 Drill Guide
Surgical Direct, Inc.
SDM18504
In Commercial Distribution

  • B382SDM185040 ()
SDM18504

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM178200

Screw Driver Element, Large, Quick Coupling, for 4.5 / 6.5mm Screws
Surgical Direct, Inc.
SDM17820
In Commercial Distribution

  • B382SDM178200 ()
SDM17820

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM178050

Small Screw Driver Element, Hexagonal, for 1.5 - 2mm Screws
Surgical Direct, Inc.
SDM17805
In Commercial Distribution

  • B382SDM178050 ()
SDM17805

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM178040

Small Screw Driver Element, Hexagonal, for 2.7 - 4mm Screws
Surgical Direct, Inc.
SDM17804
In Commercial Distribution

  • B382SDM178040 ()
SDM17804

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM17802B0

Holding Sleeve for Small Hexagonal Screw Driver, 1.5 and 2.0mm Screws
Surgical Direct, Inc.
SDM17802B
In Commercial Distribution

  • B382SDM17802B0 ()
SDM17802B

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM17802A0

Small Hexagonal Screw Driver, 1.5 and 2.0mm Screws
Surgical Direct, Inc.
SDM17802A
In Commercial Distribution

  • B382SDM17802A0 ()
SDM17802A

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM178020

Small Hexagonal Screw Driver, 1.5 and 2.0mm Screws, with Holding Sleeve
Surgical Direct, Inc.
SDM17802
In Commercial Distribution

  • B382SDM178020 ()
SDM17802

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM17801B0

Sleeve for Small Screw Driver
Surgical Direct, Inc.
SDM17801b
In Commercial Distribution

  • B382SDM17801B0 ()
SDM17801b

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM17801A0

Small Screw Driver Hexagonal
Surgical Direct, Inc.
SDM17801a
In Commercial Distribution

  • B382SDM17801A0 ()
SDM17801a

  • Surgical screwdriver, reusable

Surgical Direct - B382SDM178010

Small Screw Driver Hexagonal, Self Holding
Surgical Direct, Inc.
SDM17801
In Commercial Distribution

  • B382SDM178010 ()
SDM17801

  • Surgical screwdriver, reusable
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