Identity
- Trade Name
- Lamination pattern for outer socket FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Model / Reference
- 13E192 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04032767159970 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Myoelectric hand prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Lamination pattern for outer socket by Otto Bock Healthcare Products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Otto Bock Healthcare Products GmbH
Sources (1)
- FDA UDI f11ad6e0-6551-44e0-9a5a-e791ac309a8e 33 fields · synced May 30, 2026