Identity
- Trade Name
- AutoTouch reusable autoinjector FDA UDI
- Generic Name
- Empty self-injector, mechanical FDA UDI
- Device Name
- AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single-dose prefilled cartridge FDA UDI
- Model / Reference
- 9003600 FDA UDI
- Description
- AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single-dose prefilled cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00358406470010 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Category: Empty self-injector, mechanical
AutoTouch reusable autoinjector 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 f9d908e5-7c28-4cdb-bb25-002f83ac2c0e 34 fields · synced May 30, 2026