Omnitrope® Pen 10

FDA UDI

Class II (US FDA UDI)

by Sandoz Inc.

Identity

Trade Name: Omnitrope® Pen 10 FDA UDI
Generic Name: Empty self-injector, mechanical FDA UDI
Device Name: 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: https://www.omnitrope.com/getting-started/injection-training FDA UDI
Model / Reference: 49041459 FDA UDI
Description: 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: https://www.omnitrope.com/getting-started/injection-training FDA UDI

Identifiers

Primary DI / UDI-DI: 57622436000010 FDA UDI
FDA Product Code: NSC FDA UDI
GMDN Term: Empty self-injector, mechanical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

Yes

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HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Empty self-injector, mechanical

Omnitrope® Pen 10 by Sandoz Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sandoz Inc.

Sources (1)

FDA UDI 5743cdaa-b1a2-4c9b-8f6e-3c020de66539 34 fields · synced May 30, 2026