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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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Cryostore - 10816203020847

Cryostore 250 EVA Freezing Bag, 250ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1
Not in Commercial Distribution

  • 20816203020844 ()
  • 10816203020847 ()
  • 00816203020840 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020830

Cryostore 250 EVA Freezing Bag, 30-70ml, "F" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F
Not in Commercial Distribution

  • 20816203020837 ()
  • 10816203020830 ()
  • 00816203020833 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020816

Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y5" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000Y5
Not in Commercial Distribution

  • 10816203020816 ()
  • 20816203020813 ()


  • Blood/tissue storage/culture container

Take 1 Advanced - 10841396118248

Value Pack - Impression Material - Tray - Fast Set - 24 Cartridges (50 ml each)
KERR CORPORATION
33966
In Commercial Distribution

  • 10841396118248 ()
  • 00841396118241 ()

  • Total Volume: 1200 Milliliter


  • Silicone dental impression material

Take 1 Advanced - 10841396118224

Value Pack - Impression Material - Tray - Regular Set - 24 Cartridges (50 ml each)
KERR CORPORATION
33964
In Commercial Distribution

  • 10841396118224 ()
  • 00841396118227 ()

  • Total Volume: 1200 Milliliter


  • Silicone dental impression material

Verline Steam Autoclave Indicator Tape 1/2" x 14 YD - 24/pack - 30818087010918

Verline Steam Autoclave Indicator Tape 1/2" x 14 YD - 24/pack
PROPPER MANUFACTURING COMPANY, INC.
26814400
In Commercial Distribution

  • 10818087010914 ()
  • 30818087010918 ()
26814400

  • Chemical/physical sterilization process indicator

ICU Medical - 00887709019911

7" Smallbore 24 Hr Ext Set w/Bravo24®, Inj-Site, Luer Lock
ICU MEDICAL, INC.
B9983
In Commercial Distribution

  • 10887709019918 ()
  • 00887709019911 ()


  • Basic intravenous administration set, noninvasive

Bioness Integrated System (BITS) Mobile Configuration - 00810188050038

Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software
Bioness Medical, Inc.
BIT-2224
In Commercial Distribution



  • Perceptual-coordination assistive training device

Bioness Integrated System (BITS) Bedside Configuration - 00810188050021

Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software
Bioness Medical, Inc.
BIT-2124
In Commercial Distribution



  • Perceptual-coordination assistive training device

Dornier MedTech - 00810116021703

Bipolar Dornier Disc ™ For Vaporization 24 Fr. Electrode-Sterile, Single-Use. (6/box)
DORNIER MEDTECH AMERICA, INC.
Bipolar Dornier Disc ™ For Vaporization 24 Fr. Electrode-Sterile, Single-Use. (6
In Commercial Distribution

  • 00810116021772 ()
  • 00810116021703 ()
BIPDDSC

  • Endoscopic electrosurgical electrode, bipolar, single-use
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