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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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FullFire® Diffusing Tip Laser Probe - 00816589020151

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-4
Not in Commercial Distribution

  • 00816589020151 ()

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

  • MRI-guided laser interstitial thermal therapy system beam guide

FullFire® Diffusing Tip Laser Probe - 00816589020144

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-3
Not in Commercial Distribution

  • 00816589020144 ()

  • Outer Diameter: 3.3 Millimeter
  • Size 3
DTP-301-01

  • MRI-guided laser interstitial thermal therapy system beam guide

FullFire® Diffusing Tip Laser Probe - 00816589020137

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-2
Not in Commercial Distribution

  • 00816589020137 ()

  • Size 2
  • Outer Diameter: 3.3 Millimeter
DTP-201-01

  • MRI-guided laser interstitial thermal therapy system beam guide

FullFire® Diffusing Tip Laser Probe - 00816589020120

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-1
Not in Commercial Distribution

  • 00816589020120 ()

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

  • MRI-guided laser interstitial thermal therapy system beam guide

FullFire® Diffusing Tip Laser Probe - 00816589020113

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-000
Not in Commercial Distribution

  • 00816589020113 ()

  • Size 000
  • Outer Diameter: 3.3 Millimeter
DTP-000-01

  • MRI-guided laser interstitial thermal therapy system beam guide

FullFire® Diffusing Tip Laser Probe - 00816589020106

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-00
Not in Commercial Distribution

  • 00816589020106 ()

  • Size 00
  • Outer Diameter: 3.3 Millimeter
DTP-001-01

  • MRI-guided laser interstitial thermal therapy system beam guide

NeuroBlate® Advanced Probe Driver - 00816589020083

Probe Driver - AXiiiS (Long)
MONTERIS MEDICAL INC
20369
Not in Commercial Distribution

  • 00816589020083 ()

  • Axiiis (Long)
NBD-01

  • MRI-guided laser interstitial thermal therapy system beam guide driver

SideFire® Directional Laser Probe - 00816589020076

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-5
Not in Commercial Distribution

  • 00816589020076 ()

  • Outer Diameter: 3.3 Millimeter
  • Size 5
NBP-501-01

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020069

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

  • 00816589020069 ()

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

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020052

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-3
Not in Commercial Distribution

  • 00816589020052 ()

  • Outer Diameter: 3.3 Millimeter
  • Size 3
NBP-301-01

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020045

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-2
Not in Commercial Distribution

  • 00816589020045 ()

  • Size 2
  • Outer Diameter: 3.3 Millimeter
NBP-201-01

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020038

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-1
Not in Commercial Distribution

  • 00816589020038 ()

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

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020021

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-000
Not in Commercial Distribution

  • 00816589020021 ()

  • Size 000
  • Outer Diameter: 3.3 Millimeter
NBP-000-01

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020014

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-00
Not in Commercial Distribution

  • 00816589020014 ()

  • Size 00
  • Outer Diameter: 3.3 Millimeter
NBP-001-01

  • MRI-guided laser interstitial thermal therapy system beam guide

Arthrex® - 00888867405844

HNDL, QCK CON, 1/4 SQ, CANNULATED,IMPACT
ARTHREX, INC.
AR-2005NR
In Commercial Distribution

  • 00888867405844 ()
AR-2005NR

  • Surgical screwdriver, reusable

FullFire® Diffusing Tip Laser Probe - 00816589020823

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-000
Not in Commercial Distribution

  • 00816589020823 ()

  • Size 000
  • Outer Diameter: 3.3 Millimeter
DTP-000-01

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020816

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-000
Not in Commercial Distribution

  • 00816589020816 ()

  • Size 000
  • Outer Diameter: 3.3 Millimeter
NBP-000-01

  • MRI-guided laser interstitial thermal therapy system beam guide

FullFire® Diffusing Tip Laser Probe - 00816589020809

3.3mm Diffusing Tip Laser Probe
MONTERIS MEDICAL INC
20414-00
Not in Commercial Distribution

  • 00816589020809 ()

  • Size 00
  • Outer Diameter: 3.3 Millimeter
DTP-001-01

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020793

3.3mm Directional Laser Probe
MONTERIS MEDICAL INC
20368-00
Not in Commercial Distribution

  • 00816589020793 ()

  • Size 00
  • Outer Diameter: 3.3 Millimeter
NBP-001-01

  • MRI-guided laser interstitial thermal therapy system beam guide

SideFire® Directional Laser Probe - 00816589020786

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

SideFire® Directional Laser Probe - 00816589020779

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

FullFire® Select Diffusing Tip Laser Probe - 00816589020762

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

Arthrex® - 00888867379886

3.7MM DRILL BIT, CANNULATED, AO
ARTHREX, INC.
AR-8925DC
In Commercial Distribution

  • 00888867379886 ()
AR-8925DC

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867364271

Driver, T15 Hexalobe, 6", Straight, AO
ARTHREX, INC.
AR-8963-26
In Commercial Distribution

  • 00888867364271 ()
AR-8963-26

  • Surgical screwdriver, reusable

Arthrex® - 00888867364264

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

  • 00888867364264 ()
AR-8963-25

  • Surgical screwdriver, reusable

Arthrex® - 00888867514522

Coupler Wrench
ARTHREX, INC.
AR-8964-28
In Commercial Distribution

  • 00888867514522 ()
AR-8964-28

  • External orthopaedic fixation system, reusable

Arthrex® - 00888867500495

Driver Shaft, T15, Retaining, AO, Power
ARTHREX, INC.
AR-7650-14
In Commercial Distribution

  • 00888867500495 ()
AR-7650-14

  • Orthopaedic implant driver

Arthrex® - 00888867500488

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

  • 00888867500488 ()
AR-7650-10

  • Orthopaedic implant driver

Arthrex® - 00888867498518

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

  • 00888867498518 ()
AR-8974-50S

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498501

Reamer, Cannulated, 5.0mm
ARTHREX, INC.
AR-8974-50
In Commercial Distribution

  • 00888867498501 ()
AR-8974-50

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498495

Reamer, Ø2.8mm, AO Connect, Sterile
ARTHREX, INC.
AR-8974-28S
In Commercial Distribution

  • 00888867498495 ()
AR-8974-28S

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498488

Reamer, Ø2.8mm, AO Connect
ARTHREX, INC.
AR-8974-28
In Commercial Distribution

  • 00888867498488 ()
AR-8974-28

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498471

Reamer, Ø2.5mm, AO Connect, Sterile
ARTHREX, INC.
AR-8974-26S
In Commercial Distribution

  • 00888867498471 ()
AR-8974-26S

  • Cannulated 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
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