Identity
- Trade Name
- S-CHARGE FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Model / Reference
- 3500 mAh BATTERY FDA UDI
Identifiers
- Catalog Number
- SC3500B FDA UDI
- Primary DI / UDI-DI
- 05056701110802 FDA UDI
- FDA Product Code
- IQZ FDA UDI
- GMDN Term
- Myoelectric hand prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Myoelectric hand prosthesis
S-Charge by Hugh Steeper Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Myoelectric hand prosthesis.
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- 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
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- Luke Replaceable Part — MOBIUS BIONICS 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hugh Steeper Limited
Sources (1)
- FDA UDI 9af1eac3-e78e-41ee-a337-85306410d742 33 fields · synced Jun 8, 2026