Identity
- Trade Name
- Bipolar Cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Bipolar Scissor Cable, Reusable FDA UDI
- Model / Reference
- SIEC-BPSCC FDA UDI
- Description
- Bipolar Scissor Cable, Reusable FDA UDI
Identifiers
- Catalog Number
- SIEC-BPSCC FDA UDI
- Primary DI / UDI-DI
- 00810026180521 FDA UDI
- 510(k) Number
- K042608 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Electrical-only medical device connection cable, reusable
Bipolar Cable by Soniquence, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection cable, reusable.
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Cleared under the same submission
K042608 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
- Soniquence, LLC
Sources (1)
- FDA UDI 8489a976-c098-43bc-a653-732a7ddaaf18 35 fields · synced May 31, 2026