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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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Keri Medical SA
211-A10010
In Commercial Distribution

  • 07640181161416 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
The Omnitrope Pen 10 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 10, see: http://www.omnitrope.com/getting-started/injection-training/
Sandoz GmbH
49041459
Not in Commercial Distribution

  • 47612799222856 ()
  • 57612799210546 ()


  • Empty self-injector, mechanical
CRS Set 10
Candulor AG
662513
In Commercial Distribution

  • E1996625131 ()
662513

  • Dental articulator
Gold based noble metal
ARGEN CORPORATION, THE
100120
In Commercial Distribution

  • D818100120 ()
100120

  • Dental casting noble alloy
PERFECTEMP10 50mL CART BL-2
DEN-MAT HOLDINGS, LLC
SPD1309
In Commercial Distribution

  • D813SPD13090 ()
SPD1309

  • Dental composite resin
PERFECTEMP10 50mL CART B1
DEN-MAT HOLDINGS, LLC
SPD1308
In Commercial Distribution

  • D813SPD13080 ()
SPD1308

  • Dental composite resin
PERFECTEMP10 50mL CART A3.5
DEN-MAT HOLDINGS, LLC
SPD1307
In Commercial Distribution

  • D813SPD13070 ()
SPD1307

  • Dental composite resin
PERFECTEMP10 50mL CART A2
DEN-MAT HOLDINGS, LLC
SPD1306
In Commercial Distribution

  • D813SPD13060 ()
SPD1306

  • Dental composite resin
PERFECTEMP10 50mL CART A1
DEN-MAT HOLDINGS, LLC
SPD1305
In Commercial Distribution

  • D813SPD13050 ()
SPD1305

  • Dental composite resin
PERFECTEMP10 10mL SYR A2
DEN-MAT HOLDINGS, LLC
CR1220
In Commercial Distribution

  • D813CR12200 ()
CR1220

  • Dental composite resin
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