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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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3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-4
Not in Commercial Distribution

  • 00816589020786 ()

  • Size 4
  • Outer Diameter: 3.3 Millimeter
NBP-401-01

  • MRI-guided laser interstitial thermal therapy system beam guide
3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-1
Not in Commercial Distribution

  • 00816589020779 ()

  • Outer Diameter: 3.3 Millimeter
  • Size 1
NBP-101-01

  • MRI-guided laser interstitial thermal therapy system beam guide
2.2mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20624-3
Not in Commercial Distribution

  • 00816589020762 ()

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

  • MRI-guided laser interstitial thermal therapy system beam guide
3.7MM DRILL BIT, CANNULATED, AO
ARTHREX, INC.
AR-8925DC
In Commercial Distribution

  • 00888867379886 ()
AR-8925DC

  • Cannulated surgical drill bit, single-use
Driver, T15 Hexalobe, 6", Straight, AO
ARTHREX, INC.
AR-8963-26
In Commercial Distribution

  • 00888867364271 ()
AR-8963-26

  • Surgical screwdriver, reusable
Driver, T15 Hexalobe, 6", AO
ARTHREX, INC.
AR-8963-25
In Commercial Distribution

  • 00888867364264 ()
AR-8963-25

  • Surgical screwdriver, reusable
Coupler Wrench
ARTHREX, INC.
AR-8964-28
In Commercial Distribution

  • 00888867514522 ()
AR-8964-28

  • External orthopaedic fixation system, reusable
Driver Shaft, T15, Retaining, AO, Power
ARTHREX, INC.
AR-7650-14
In Commercial Distribution

  • 00888867500495 ()
AR-7650-14

  • Orthopaedic implant driver
Driver Shaft, T15, Non-retaining, AO
ARTHREX, INC.
AR-7650-10
In Commercial Distribution

  • 00888867500488 ()
AR-7650-10

  • Orthopaedic implant driver
Reamer, Cannulated, 5.0mm, Sterile
ARTHREX, INC.
AR-8974-50S
In Commercial Distribution

  • 00888867498518 ()
AR-8974-50S

  • Cannulated surgical drill bit, single-use
Reamer, Cannulated, 5.0mm
ARTHREX, INC.
AR-8974-50
In Commercial Distribution

  • 00888867498501 ()
AR-8974-50

  • Cannulated surgical drill bit, single-use
Reamer, Ø2.8mm, AO Connect, Sterile
ARTHREX, INC.
AR-8974-28S
In Commercial Distribution

  • 00888867498495 ()
AR-8974-28S

  • Cannulated surgical drill bit, single-use
Reamer, Ø2.8mm, AO Connect
ARTHREX, INC.
AR-8974-28
In Commercial Distribution

  • 00888867498488 ()
AR-8974-28

  • Cannulated surgical drill bit, single-use
Reamer, Ø2.5mm, AO Connect, Sterile
ARTHREX, INC.
AR-8974-26S
In Commercial Distribution

  • 00888867498471 ()
AR-8974-26S

  • Cannulated 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
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