Identity
- Trade Name
- Remote Electrode FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Model / Reference
- 13E400=G90-50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04032767938155 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
- 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
Category: Myoelectric hand prosthesis
Remote Electrode by Otto Bock Healthcare Products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoelectric hand prosthesis.
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- S-CHARGE — HUGH STEEPER LIMITED · Class I
- Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
- Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- BATTERY SYSTEM — HUGH STEEPER LIMITED · Class I
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- Luke Replaceable Part — MOBIUS BIONICS LLC · 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
- Otto Bock Healthcare Products GmbH
Sources (1)
- FDA UDI 22e7036e-f42a-49e6-aeee-30ff20584b92 32 fields · synced May 30, 2026