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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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Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Guide
Dev4
CT-2000NS
In Commercial Distribution

  • 00860011634829 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPINERY Generator (REF: SPINERY) is a RadioFrequency Generator used for parameter control and treatment modulation; equipped with a peristaltic pump intended to allow the flow of a close cooling fluid (sterile saline water) inside RF electrode needles during ablation procedure. A Footswitch, used to control the activation and interruption of the ablation, is provided together with the Generator. A Stainless-Steel rod is also provided to hang up the sterile water bag for used for cooling system circuit.
AXON SRL
SPINERY
In Commercial Distribution

  • 00860011603665 ()


  • Percutaneous radio-frequency ablation system generator
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-4NS
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
Guide anchor screws with dental support Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469278 ()
GASDSTI

  • Custom-made orthopaedic/craniofacial surgical guide
BSSO Surgical Guide with Dental Support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469261 ()
GCSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
BSSO Surgical Guide - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469230 ()
GCSTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthognathic Surgical Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469223 ()
FPCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthognathic Surgical Splint - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469216 ()
FPCOTI

  • Custom-made orthopaedic/craniofacial surgical guide
Dental needle safety device.
Dental Products Lab, LLC
8000-01
In Commercial Distribution

  • 00860011428411 ()
NPG-5-PCK

  • Needle recapping device, reusable
Dental needle safety device.
Dental Products Lab, LLC
8000-01
In Commercial Distribution

  • 00860011428404 ()
NPG-SNG-PCK

  • Needle recapping device, reusable
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