Identity
- Trade Name
- Alpine Biomed FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- HUSH Reusable Bar Electrode, 2 x 10 mm discs, 30mm apart,shielded 1m cable, 5-pin DIN connector FDA UDI
- Model / Reference
- 9013S0352 FDA UDI
- Description
- HUSH Reusable Bar Electrode, 2 x 10 mm discs, 30mm apart,shielded 1m cable, 5-pin DIN connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704736000598 FDA UDI
- 510(k) Number
- K934580 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use 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 88a0a799-39f8-437a-83b9-a513e80a0ba6 35 fields · synced May 30, 2026