Omnitrope Pen 10

GUDID 49002269218553

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 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 10, see: http://www.omnitope.com/getting-started/injection-training/

Sandoz GmbH

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• Primary Device ID: 49002269218553
• NIH Device Record Key: ec9efa49-3460-4fa9-bb09-885210b01193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnitrope Pen 10
• Version Model Number: 49041459
• Company DUNS: 300220969
• Company Name: Sandoz GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com
• Phone: 8005258747
• Email: medicalaffairs.us@sandoz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	49002269218553 [Direct Marking]
GS1	59002269207349 [Primary]

FDA Product Code

• NSC: Injector, Pen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-15
• Device Publish Date: 2023-02-07

On-Brand Devices [Omnitrope Pen 10]

• 49002269218553: The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pe
• 47612799222856: The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pe