Identity
- Trade Name
- Alpine Biomed FDA UDI
- Generic Name
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
- Device Name
- Hand-held Bipolar Stimulator, Two 3 mm felt tips, diameter pads 10 mm apart, 2 m cable, 5-pin DIN FDA UDI
- Model / Reference
- 9013L0352 FDA UDI
- Description
- Hand-held Bipolar Stimulator, Two 3 mm felt tips, diameter pads 10 mm apart, 2 m cable, 5-pin DIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704736000475 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Diagnostic peripheral nerve electrical stimulation system 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
Yes
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
Alpine Biomed by Alpine Biomed Aps — 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
- Alpine Biomed Aps
Sources (1)
- FDA UDI 16b22021-7a10-4aa4-bc84-10d13ad1d9ff 34 fields · synced Jun 1, 2026