Identity
- Trade Name
- Corkscew Electrode FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Corkscrew electrode CS-F (2m) 003-400001-4. Four twisted electrodes in double package to preserve sterility of the product. Use for one medical operation. FDA UDI
- Model / Reference
- 003-400001-4 FDA UDI
- Description
- Corkscrew electrode CS-F (2m) 003-400001-4. Four twisted electrodes in double package to preserve sterility of the product. Use for one medical operation. FDA UDI
Identifiers
- Catalog Number
- 003-400001-4 FDA UDI
- Primary DI / UDI-DI
- 00852373007229 FDA UDI
- 510(k) Number
- K934779 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1350 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 — 2 Meter FDA UDI
Category: Subdermal needle electrode
Corkscew Electrode by SGM d.o.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K934779 also covers:
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 aadd26e6-0151-4fa9-bfa5-e9001047b616 37 fields · synced Jun 8, 2026