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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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Maxilla Model
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469254 ()
MAPMAXI

  • Custom-made organ/bone anatomy model
Mandible Model
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469247 ()
MAPMANI

  • Custom-made organ/bone anatomy model
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
Complete Maxillofacial Model (fused)
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469209 ()
MAPMANIFZD

  • Custom-made organ/bone anatomy model
No Description
Quick Tube Medical, LLC
CTD-16
In Commercial Distribution

  • 10860011294709 ()
  • 00860011294702 ()


  • Pleural catheter
BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment software
Precision Cut EBT3 GafChromic(TM) Film
Computerized Imaging Reference Systems, Inc.
158200
Not in Commercial Distribution

  • 00860011127406 ()
158200

  • Medical x-ray film, non-screen
The Sterilization indicator tape is designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off-yellow to Dark brown/Black. Use the Sterilization indicator tape in steam sterilization processes described below. 1. 121°C, 30 minutes; Gravity Steam 2. 132°C, 4 minutes; Dynamic Air Removal Steam 3. 135°C, 3 minutes; Dynamic Air Removal Steam
True Indicating LLC
CSWN-1T
In Commercial Distribution

  • 00860011103424 ()


  • Chemical/physical sterilization process indicator
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