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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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Pall® Oxygenator Gas Line Filter - 05034480000446

Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases.
Pall International Sàrl
ORO1H
In Commercial Distribution

  • 35034480000447 ()
  • 05034480000446 ()

  • >99.999% airborne bacterial removal efficiency
ORO1H

  • Microbial medical gas filter, sterile, single-use

Randox Evidence™ - 05055273214024

The RANDOX evidence® system is a fully automated, continuous access immunoanalyser using protein biochip array technology. It is intended for the in-vitro qualitative, semi-quantitative or fully quantitative determination of various diagnostic markers.
RANDOX LABORATORIES LIMITED
EV3600
In Commercial Distribution

  • 05055273214024 ()
EV3600

  • Multiplex analyser IVD, laboratory, automated

Urinary Drainage Bag Holder - 00616784026138

No Description
Dynarex Corporation
10261
In Commercial Distribution

  • 00616784026138 ()
  • 00616784026114 ()


  • Open-ended non-wearable urine collection bag, non-sterile

RestoreADVANCED™ - 00613994842367

INS 37713 RESTORE ADV eMAN BLUE WRENCH
MEDTRONIC, INC.
37713
In Commercial Distribution

  • 00613994842367 ()


  • Analgesic spinal cord electrical stimulation system

RestorePRIME™ - 00613994842299

INS 37701 RESTR PRIME BLUE TORQ WRNCH US
MEDTRONIC, INC.
37701
Not in Commercial Distribution

  • 00613994842299 ()


  • Analgesic spinal cord electrical stimulation system

NA - 00848838004469

No Description
REMEL, INC.
R04030
In Commercial Distribution

  • 00848838004469 ()
  • 00848838099571 ()


  • Neiserria species agar culture medium IVD, basic

NA - 00848838003738

No Description
REMEL, INC.
R02058
In Commercial Distribution

  • 00848838003738 ()
  • 00848838099557 ()


  • Thayer-Martin Neisseria species agar culture medium IVD

NA - 00848838003288

No Description
REMEL, INC.
R01882
In Commercial Distribution

  • 00848838003288 ()
  • 00848838099946 ()


  • Thayer-Martin Neisseria species agar culture medium IVD

NA - 00848838003271

No Description
REMEL, INC.
R01881
In Commercial Distribution

  • 00848838003271 ()
  • 00848838099724 ()


  • Thayer-Martin Neisseria species agar culture medium IVD

NA - 00848838003264

No Description
REMEL, INC.
R01880
In Commercial Distribution

  • 00848838003264 ()
  • 00848838099533 ()


  • Thayer-Martin Neisseria species agar culture medium IVD
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