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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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Twist Drill, 5/16”
SYMMETRY MEDICAL INC.
11-001-400
In Commercial Distribution

  • 00847538007961 ()
2709-01-015;00-9986-010-26;430032

  • Fluted surgical drill bit, reusable
No Description
BIOCARE MEDICAL LLC
API3025AA
In Commercial Distribution

  • 00847627003959 ()


  • Cytokeratin IVD, antibody
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
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34572-61
In Commercial Distribution

  • 00810929019423 ()
  • 00810929019416 ()


  • Instrument anti-oxidation agent
No Description
Roche Diagnostics GmbH
05918081190
In Commercial Distribution

  • 07613336180877 ()
05918081190

  • Thyroglobulin IVD, control
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
No Description
ROCKWELL MEDICAL, INC.
R-100
In Commercial Distribution

  • 00814963021121 ()
  • 10814963021128 ()
R-100

  • Haemodialysis concentrate
No Description
BIOMET MICROFIXATION, INC
91-6804-5PK
In Commercial Distribution

  • 00888233025317 ()
91-6804-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Pacetrak Plus Rev 5(PP5-Pactrak Plus ENR)
In Commercial Distribution

  • B147PACETRAKPLUSENR0 ()


  • Electrocardiography telemetric monitoring system
Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Heartrak Smart Rev 5
In Commercial Distribution

  • B147HTSM50 ()


  • Electrocardiography telemetric monitoring system
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