Identity
- Trade Name
- Twisted Pair Needle Electrode FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation. FDA UDI
- Model / Reference
- 003-400124-3 FDA UDI
- Description
- Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation. FDA UDI
Identifiers
- Catalog Number
- 003-400124-3 FDA UDI
- Primary DI / UDI-DI
- 00852373007083 FDA UDI
- 510(k) Number
- K010019 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
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDILength — 2 Meter FDA UDI
Category: Electromyographic needle electrode, single-use
Twisted Pair Needle Electrode by SGM d.o.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- SGM d.o.o.
Sources (1)
- FDA UDI a42e6315-0d7b-4d30-9739-2b8e40a37f7e 37 fields · synced May 30, 2026