Identity
- Trade Name
- Skytrofa Auto-Injector FDA UDI
- Generic Name
- Empty self-injector, electronic FDA UDI
- Model / Reference
- 1002247 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713495000077 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- Empty self-injector, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 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
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
Category: Empty self-injector, electronic
Skytrofa Auto-Injector by Phillips-Medisize A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Empty self-injector, electronic.
- SKYTROFA Auto-Injector — Phillips-Medisize A/S · Class II
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
- Phillips-Medisize A/S
Sources (1)
- FDA UDI 30303305-0891-4975-9f3f-2d55c0e2376b 32 fields · synced May 30, 2026