Repatha Pushtronex System, sample

FDA UDI

Class II (US FDA UDI)

by Amgen Inc.

Identity

Trade Name: Repatha Pushtronex System, sample FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: On-Body Infusor and Prefilled Cartridge, sample FDA UDI
Model / Reference: 9003243 FDA UDI
Description: On-Body Infusor and Prefilled Cartridge, sample FDA UDI

Identifiers

Primary DI / UDI-DI: 00355513770910 FDA UDI
FDA Product Code: FRN FDA UDI
GMDN Term: Autoinjector needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Total Volume — 3.5 Milliliter FDA UDI

Category: Autoinjector needle

Repatha Pushtronex System, sample by Amgen 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: Amgen Inc.

Sources (1)

FDA UDI 9b22dd54-b2ed-4744-8d1b-d06c70efc175 35 fields · synced Jun 7, 2026