Identity
- Trade Name
- Repatha Pushtronex System FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- On-Body Infusor and Prefilled Cartridge FDA UDI
- Model / Reference
- 9006655 FDA UDI
- Description
- On-Body Infusor and Prefilled Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00372511770018 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3.5 Milliliter FDA UDI
Category: Autoinjector needle
Repatha Pushtronex System 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 881a7ffb-c1d9-43d9-8129-cd9e7f79e97c 35 fields · synced May 30, 2026