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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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A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin growth hormone inserted into the device.
PHARMACIA & UPJOHN COMPANY LLC
F000116153
In Commercial Distribution

  • 10300134761929 ()


  • Empty self-injector, mechanical
No Description
Biomet Orthopedics, LLC
29409
In Commercial Distribution

  • 00888480266099 ()
29409

  • Orthopaedic implant-instrument extension adaptor, reusable
No Description
BIOMET MICROFIXATION, INC
91-6604-5PK
In Commercial Distribution

  • 00888233012263 ()
91-6604-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
BIOMET MICROFIXATION, INC
91-6804-5PK
In Commercial Distribution

  • 00888233025317 ()
91-6804-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution

  • 10385083000503 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
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: https://www.omnitrope.com/getting-started/injection-training
Sandoz Inc.
49041480
In Commercial Distribution

  • 47612799222849 ()
  • 57622436000027 ()
  • 59002269207349 ()


  • Empty self-injector, mechanical
Gold based noble metal
ARGEN CORPORATION, THE
115809
In Commercial Distribution

  • D818115809 ()
115809

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115807
In Commercial Distribution

  • D818115807 ()
115807

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115806
In Commercial Distribution

  • D818115806 ()
115806

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115805
In Commercial Distribution

  • D818115805 ()
115805

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115777
In Commercial Distribution

  • D818115777 ()
115777

  • Dental casting noble alloy
Base metal alloy
ARGEN CORPORATION, THE
100437
In Commercial Distribution

  • D818100437 ()
100437

  • Dental casting non-noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
121792
In Commercial Distribution

  • D818121792 ()
121792

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
121782
In Commercial Distribution

  • D818121782 ()
121782

  • Dental casting noble alloy
Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
121289
In Commercial Distribution

  • D818121289 ()
121289

  • Dental porcelain/ceramic restoration kit
Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
121283
In Commercial Distribution

  • D818121283 ()
121283

  • Dental porcelain/ceramic restoration kit
Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
121277
In Commercial Distribution

  • D818121277 ()
121277

  • Dental porcelain/ceramic restoration kit
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