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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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Howard Leight - 00033552015260

Impact Sport Sound Amplification Electronic Earmuff, Hunter Green
SPERIAN HEARING PROTECTION, LLC
Impact Sport
In Commercial Distribution

  • 10033552015267 ()
  • 00033552015260 ()
R-01526

  • Acoustic earmuffs

Cook - 00827002302648

Biliary Drainage Catheter Ultrathane
COOK INCORPORATED
G30264
In Commercial Distribution

  • 00827002302648 ()
ULT10.2-38-40-P-CLBS-14.5-RH

  • Biliary drain

Cook - 00827002289451

Biliary Drainage Catheter Ultrathane
COOK INCORPORATED
G28945
In Commercial Distribution

  • 00827002289451 ()
ULT8.5-38-25-P-32S-CLB-RH

  • Biliary drain

Cook - 00827002289352

Biliary Drainage Catheter Ultrathane
COOK INCORPORATED
G28935
In Commercial Distribution

  • 00827002289352 ()
ULT14.0-38-50-P-32S-CLB-RH

  • Biliary drain

Cook - 00827002289246

Biliary Drainage Catheter Ultrathane
COOK INCORPORATED
G28924
In Commercial Distribution

  • 00827002289246 ()
ULT12.0-38-50-P-32S-CLB-RH

  • Biliary drain

Cook - 00827002289222

Biliary Drainage Catheter Ultrathane
COOK INCORPORATED
G28922
In Commercial Distribution

  • 00827002289222 ()
ULT12.0-38-40-P-CLBS-28-RH

  • Biliary drain

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

CUSA® Excel - 10381780248248

The extended life laparoscopic tip is intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. The CUSA Excel System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: • Neurosurgery • Gastrointestinal and affiliated organ surgery • Urological surgery • Plastic and reconstructive surgery • General surgery • Orthopedic surgery • Gynecological surgery • Thoracic surgery • Laparoscopic surgery • Thoracoscopic surgery
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C4604ELTUS
In Commercial Distribution

  • 30381780248242 ()
  • 10381780248248 ()
  • M269C4604ELTUS1 ()

  • Length 30.14 cm; Diameter 1.98mm


  • Soft-tissue ultrasonic surgical system handpiece tip, reusable

FacetLink System - 04026575426621

Facet Screw
WALDEMAR LINK GmbH & Co. KG
80-1011/55
In Commercial Distribution

  • 04026575426621 ()

  • Length=55mm
80-1011/55

  • Spinal bone screw, non-bioabsorbable

FacetLink System - 04026575426614

Facet Screw
WALDEMAR LINK GmbH & Co. KG
80-1011/50
In Commercial Distribution

  • 04026575426614 ()

  • Length=50mm
80-1011/50

  • Spinal bone screw, non-bioabsorbable
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