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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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CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
LW N° 5
Cendres+Métaux SA
01050041_1PC
Not in Commercial Distribution

  • 97640173080254 ()
01050041

  • Dental brazing alloy
The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 5, see: http://www.omnitrope.com/getting-started/injection-training/
Sandoz GmbH
49036229
Not in Commercial Distribution

  • 49002269218553 ()
  • 59002269207349 ()


  • Empty self-injector, mechanical
Distal Access Catheter
Stryker Corporation
M003IC0581150
In Commercial Distribution

  • 07613327012019 ()

  • Length: 115.0 Centimeter
  • Lumen/Inner Diameter: 0.058 Inch
IC058115

  • Vascular guide-catheter, single-use
Distal Access Catheter
Stryker Corporation
M003IC0581320
In Commercial Distribution

  • 07613327011999 ()

  • Lumen/Inner Diameter: 0.058 Inch
  • Length: 132.0 Centimeter
IC058132

  • Vascular guide-catheter, single-use
No Description
BIOGENEX LABORATORIES
NU892-UC
In Commercial Distribution

  • 00810119679031 ()

  • Total Volume: 1 Milliliter
NU892-UC

  • Multiple squamous cell carcinoma-associated marker IVD, antibody
No Description
ACCUTRON, INC.
34016
In Commercial Distribution

  • 00813830021813 ()
34016

  • Anaesthesia workstation gas scavenger
No Description
Biomet Orthopedics, LLC
29410
In Commercial Distribution

  • 00888480266105 ()
29410

  • Orthopaedic inorganic implant inserter/extractor, reusable
Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution

  • 20385083000531 ()
  • 10385083000527 ()
  • 20385083000579 ()
  • 20385083000753 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-BLE-H1-520
In Commercial Distribution

  • 10385083000213 ()
  • 10385083000114 ()
  • 10385083000138 ()
  • 20385083000210 ()
  • 20385083000135 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
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