Omnitrope Pen 5

GUDID 47612799222849

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 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 patient unable to perform the injection themselves. For information on the use of Omnitrope 5, see: http://www.omnitope.com/getting-started/injection-training/

Sandoz GmbH

Cartridge-accepting autoinjector, mechanical
Primary Device ID47612799222849
NIH Device Record Key15349f39-2db7-40a5-b4a8-5dfa3027f53a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnitrope Pen 5
Version Model Number49041480
Company DUNS300220969
Company NameSandoz GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone8005258747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com
Phone800-525-8747
Emailmedicalaffairs.us@sandoz.com

Device Identifiers

Device Issuing AgencyDevice ID
GS147612799222849 [Direct Marking]
GS157612799207348 [Primary]
GS157622436000027 [Primary]
GS159002269207349 [Previous]

FDA Product Code

NSCInjector, Pen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-15
Device Publish Date2023-02-07

Devices Manufactured by Sandoz GmbH

47612799222856 - Omnitrope Pen 102023-04-03 The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcut
47612799222849 - Omnitrope Pen 52023-02-15The 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 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 patient unable to perform the injection themselves. For information on the use of Omnitrope 5, see: http://www.omnitope.com/getting-started/injection-training/
47612799222849 - Omnitrope Pen 52023-02-15 The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcuta
49002269218553 - Omnitrope Pen 102023-02-15 The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcut
57613421039603 - Glatopaject®2020-10-27 The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for
59002269209466 - Glatopaject®2018-03-29 The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for
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