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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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PermaLife - 10816203023251

PermaLife Cell Culture bag, 750ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL750N
In Commercial Distribution

  • 10816203023251 ()
PL750N

  • Blood/tissue storage/culture container

PermaLife - 10816203023244

PermaLife Cell Culture Bag, 120ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL120N
In Commercial Distribution

  • 10816203023244 ()
PL120N

  • Blood/tissue storage/culture container

PermaLife - 10816203023237

PermaLife Cell Culture Bag, 325ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL325N
In Commercial Distribution

  • 10816203023237 ()
PL325N

  • Blood/tissue storage/culture container

PermaLife - 10816203022377

PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
Not in Commercial Distribution

  • 10816203022377 ()


  • Blood/tissue storage/culture container

PermaLife - 00816203021762

PermaLife Cell Culture Bag, 120ml, with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution

  • 10816203021769 ()
  • 00816203021762 ()


  • Blood/tissue storage/culture container

Korebalance Premiere - 00858458007009

The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.
Diversified Healthcare Development, LLC
KB01
In Commercial Distribution

  • 00858458007009 ()


  • Balance/cognitive function analysis system

RS - 00860000737005

Blood Irradiator
RAD SOURCE TECHNOLOGIES, INC.
3400
In Commercial Distribution

  • 00860000737005 ()


  • In vitro ionizing-radiation blood irradiator

Kolibri - 05701780271394

No Description
Coloplast A/S
RCM014
In Commercial Distribution

  • 05701780271417 ()
  • 05701780271400 ()
  • 05701780271394 ()

  • Catheter Gauge: 14 French
RCM014

  • Nephrostomy catheter

Kolibri - 05701780271356

No Description
Coloplast A/S
RCM012
In Commercial Distribution

  • 05701780271363 ()
  • 05701780271356 ()
  • 05701780271387 ()

  • Catheter Gauge: 12 French
RCM012

  • Nephrostomy catheter

Kolibri - 05701780271325

No Description
Coloplast A/S
RCM010
In Commercial Distribution

  • 05701780271332 ()
  • 05701780271325 ()
  • 05701780271349 ()

  • Catheter Gauge: 10 French
RCM010

  • Nephrostomy catheter
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