Identity
- Trade Name
- Bipolar Cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- IEC Bipolar Cord, Reusable FDA UDI
- Model / Reference
- SIEC-JX/B FDA UDI
- Description
- IEC Bipolar Cord, Reusable FDA UDI
Identifiers
- Catalog Number
- SIEC-JX/B FDA UDI
- Primary DI / UDI-DI
- 00810026180507 FDA UDI
- 510(k) Number
- K211946 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
K211946 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 fdfe47ef-524c-48ac-8a5a-fdcec7212222 35 fields · synced May 30, 2026