Omnitrope® Pen 5

FDA UDI

Class II (US FDA UDI)

by Sandoz Inc.

Identity

Trade Name: Omnitrope® Pen 5 FDA UDI
Generic Name: Empty self-injector, mechanical FDA UDI
Device Name: 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 FDA UDI
Model / Reference: 49041480 FDA UDI
Description: 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 57622436000027 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 5 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 3498bd6f-7e20-42e8-bece-ffb3c5035dfa 34 fields · synced May 30, 2026