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

  • 00888867220003 ()
AR-8950SD-08

  • Cannulated surgical drill bit, single-use
Smileclip Abutment Driver - Short
RODO MEDICAL, INC.
90.600
In Commercial Distribution

  • 00816131023678 ()


  • Surgical screwdriver, reusable
Smileclip Abutment Driver - Medium
RODO MEDICAL, INC.
90.601
In Commercial Distribution

  • 00816131023432 ()
90.601

  • Surgical screwdriver, reusable
Abutment Socket Driver - Short
RODO MEDICAL, INC.
90.003
In Commercial Distribution

  • 00816131023173 ()
90.003

  • Surgical screwdriver, reusable
Abutment Socket Driver - Medium
RODO MEDICAL, INC.
90.002
In Commercial Distribution

  • 00816131023166 ()
90.002

  • Surgical screwdriver, reusable
No Description
SURETEK MEDICAL
HT-1120
In Commercial Distribution

  • B390HT11201 ()


  • Fluted surgical drill bit, single-use
No Description
SURETEK MEDICAL
57S02025
In Commercial Distribution

  • B39057S020251 ()


  • Drilling power tool attachment, basic
No Description
SURETEK MEDICAL
57S02020
In Commercial Distribution

  • B39057S020201 ()


  • Drilling power tool attachment, basic
VerteLP Angled Implant Inserter Ball-end Hex Driver
VGI MEDICAL, LLC
VLP-BALLHEX
In Commercial Distribution

  • B387VLPBALLHEX0 ()
VLPBALLHEX

  • Orthopaedic fixation implant alignment tool
Bone Mallet, 500g.
Surgical Direct, Inc.
SDM33050
In Commercial Distribution

  • B382SDM330500 ()
SDM33050

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

  • B382SDM188000 ()
SDM18800

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

  • B382SDM187000 ()
SDM18700

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

  • B382SDM185140 ()
SDM18514

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

  • B382SDM185130 ()
SDM18513

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

  • B382SDM185080 ()
SDM18508

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

  • B382SDM1850750 ()
SDM185075

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

  • B382SDM185070 ()
SDM18507

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

  • B382SDM185060 ()
SDM18506

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

  • B382SDM185050 ()
SDM18505

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

  • B382SDM185040 ()
SDM18504

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

  • B382SDM178200 ()
SDM17820

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

  • B382SDM178050 ()
SDM17805

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

  • B382SDM178040 ()
SDM17804

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

  • B382SDM17802A0 ()
SDM17802A

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

  • B382SDM17801B0 ()
SDM17801b

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

  • B382SDM17801A0 ()
SDM17801a

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

  • B382SDM178010 ()
SDM17801

  • Surgical screwdriver, reusable
Large Screw Driver Hexagonal, for 4.5 / 6.5mm Screws
Surgical Direct, Inc.
SDM17603
In Commercial Distribution

  • B382SDM176030 ()
SDM17603

  • Surgical screwdriver, reusable
Hexagonal Head Screwdriver for 2.7 & 3.5/4.0mm Screws
Surgical Direct, Inc.
SDM17602
In Commercial Distribution

  • B382SDM176020 ()
SDM17602

  • Surgical screwdriver, reusable
Hexagonal Head Screwdriver for 1.5 & 2.0mm Screws
Surgical Direct, Inc.
SDM17601
In Commercial Distribution

  • B382SDM176010 ()
SDM17601

  • Surgical screwdriver, reusable
Countersink for Quick Coupling for Screws 4.5 and 6.5mm Screws
Surgical Direct, Inc.
SDM17301
In Commercial Distribution

  • B382SDM173010 ()
SDM17301

  • Surgical screwdriver, reusable
Handle, with Mini Coupling
Surgical Direct, Inc.
SDM17204
In Commercial Distribution

  • B382SDM172040 ()
SDM17204

  • Surgical screwdriver, reusable
Handle for Quick Coupling
Surgical Direct, Inc.
SDM17203
In Commercial Distribution

  • B382SDM172030 ()
SDM17203

  • Surgical screwdriver, reusable
Handle with Quick Coupling, for Taps
Surgical Direct, Inc.
SDM17201
In Commercial Distribution

  • B382SDM172010 ()
SDM17201

  • Surgical screwdriver, reusable
Cross Recessed Screw Driver Endpiece for 2.0mm Screws
Surgical Direct, Inc.
SDL51902
In Commercial Distribution

  • B382SDL519020 ()
SDL51902

  • Surgical screwdriver, reusable
Cross Recessed Screw Driver Endpiece for 1.5mm Screws
Surgical Direct, Inc.
SDL51802
In Commercial Distribution

  • B382SDL518020 ()
SDL51802

  • Surgical screwdriver, reusable
Screw Driver Handle for 1.0, 1.5, and 2.0 Screws
Surgical Direct, Inc.
SDL51020
In Commercial Distribution

  • B382SDL510200 ()
SDL51020

  • Surgical screwdriver, reusable
3.3mm x 8mm x 5mm Hex Driver SR
MONTERIS MEDICAL INC
20816
In Commercial Distribution

  • 00816589021523 ()

  • Outer Diameter: 3.3 Millimeter
20816

  • Neurological stereotactic surgery system
2.2mm x 8mm x 5mm Hex Driver SR
MONTERIS MEDICAL INC
20814
In Commercial Distribution

  • 00816589021509 ()

  • Lumen/Inner Diameter: 2.2 Millimeter
20814

  • Neurological stereotactic surgery system
Specialized Driver Kit for Varioguide Adapter
MONTERIS MEDICAL INC
20637
In Commercial Distribution

  • 00816589021417 ()

  • Outer Diameter: 3.3 Millimeter
CMB-SD

  • Neurological stereotactic surgery system
6mm Specialized Driver for 2.2mm Mini-Bolt
MONTERIS MEDICAL INC
20677
In Commercial Distribution

  • 00816589021332 ()

  • Outer Diameter: 2.2 Millimeter
CMB022-SD

  • Neurological stereotactic surgery system
T-Handle for 5mm Hex Driver
MONTERIS MEDICAL INC
20820
In Commercial Distribution

  • 00816589021264 ()

  • Lumen/Inner Diameter: 5 Millimeter
20820

  • Neurological stereotactic surgery system
2.2mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20895-5
In Commercial Distribution

  • 00816589021073 ()

  • Size 5
  • Outer Diameter: 2.2 Millimeter
FFS522-01

  • MRI-guided laser interstitial thermal therapy system beam guide
2.2mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20895-4
In Commercial Distribution

  • 00816589021066 ()

  • Outer Diameter: 2.2 Millimeter
  • Size 4
FFS422-01

  • MRI-guided laser interstitial thermal therapy system beam guide
2.2mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20895-3
In Commercial Distribution

  • 00816589021059 ()

  • Outer Diameter: 2.2 Millimeter
  • Size 3
FFS322-01

  • MRI-guided laser interstitial thermal therapy system beam guide
2.2mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20895-2
In Commercial Distribution

  • 00816589021042 ()

  • Outer Diameter: 2.2 Millimeter
  • Size 2
FFS222-01

  • MRI-guided laser interstitial thermal therapy system beam guide
2.2mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20895-1
In Commercial Distribution

  • 00816589021035 ()

  • Outer Diameter: 2.2 Millimeter
  • Size 1
FFS122-01

  • MRI-guided laser interstitial thermal therapy system beam guide
2.2mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20895-000
In Commercial Distribution

  • 00816589021028 ()

  • Outer Diameter: 2.2 Millimeter
  • Size 000
FFS000-01

  • MRI-guided laser interstitial thermal therapy system beam guide
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