Identity
- Trade Name
- BASCH Cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- 1600342 FDA UDI
Identifiers
- Catalog Number
- 1600342-001 FDA UDI
- Primary DI / UDI-DI
- J00716003420011 FDA UDI
- 510(k) Number
- K792159 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
BASCH Cable by Bien-Air Surgery SA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K792159 also covers:
- BASCH Micromotor — Bien-Air Surgery SA
- BASCH Micromotor + Cable — Bien-Air Surgery SA
- BASCH Micromotor + Cable — Bien-Air Surgery SA
- BASCH-1 Micromotor — Bien-Air Surgery SA
- BASCH-1 Micromotor + Cable — Bien-Air Surgery SA
- OSSEODOC Control Unit — Bien-Air Surgery SA
- OSSEODOC Control Unit + Pump — Bien-Air Surgery SA
- OSSEODOC Foot Pedal — Bien-Air Surgery SA
- PM 1124 46mm — Bien-Air Surgery SA
- PMAM 1122 125mm — Bien-Air Surgery SA
- PMAM 1122 70mm — Bien-Air Surgery SA
- PMAM 1122 95mm — Bien-Air Surgery SA
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Surgery SA
Sources (2)
- FDA UDI cbd7e58d-b093-49e4-9a07-2fe225b2f9ea 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026