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

  • 00860011469247 ()
MAPMANI

  • Custom-made organ/bone anatomy model
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
Pin Site Sponge
Os Medica, LLC
950S
In Commercial Distribution

  • 00860011062608 ()
  • 00860011062615 ()
  • 50860011062603 ()
950S

  • Wound-nonadherent dressing, absorbent, non-antimicrobial
No Description
Anthrotronix, Inc.
1.0
In Commercial Distribution

  • 00860011042105 ()


  • Cognitive assessment software
Binder Transfer slide sheet for Stryker Pro XT and Pro 2 models (Sheet only)
We Stitch Stuff, LLC
BT-SS2-BL
In Commercial Distribution

  • 00860010986561 ()
BT-SS2-BL

  • Patient transfer/turning sheet, reusable
Binder Transfer Stryker Bundle (Sheet/Transer-aid with set of 8 anchors)
We Stitch Stuff, LLC
BT-SB1-BL
In Commercial Distribution

  • 00860010986554 ()
BT-SB1-BL

  • Patient transfer/turning sheet, reusable
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