Identity
- Trade Name
- Alpine Biomed FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Sensory Needle Electrode, 15 mm 0.35 mm (28G) Reference 3.5 mm2 FDA UDI
- Model / Reference
- 9013R0243 FDA UDI
- Description
- Disposable Sensory Needle Electrode, 15 mm 0.35 mm (28G) Reference 3.5 mm2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704736002066 FDA UDI
- FDA Product Code
- IKT FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1385 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
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 a181f845-ee04-4e4d-94c1-d71061905248 34 fields · synced Jun 8, 2026