Cable for Perforator Motor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Cable for Perforator Motor EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- 362642 EUDAMEDFDA UDIPM PERFO Cable EUDAMED
Identifiers
- Catalog Number
- 1601111-001 FDA UDI
- Primary DI / UDI-DI
- 07630055507792 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300555_004_EZ EUDAMED
- Direct Marketing DI
- 07630055507792 EUDAMED
- 510(k) Number
- K173066 FDA UDI
- FDA Product Code
- HBC FDA UDIHBE FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4360 FDA UDI882.4310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Cable for Perforator Motor by Bien-Air Surgery SA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K173066 also covers:
- Bur Cranial Spiral 10mm St — Bien-Air Surgery SA
- Bur Cranial Spiral 15mm St — Bien-Air Surgery SA
- Bur Cranial Spiral 25mm St — Bien-Air Surgery SA
- Bur Cranial Straight 10mm St — Bien-Air Surgery SA
- Bur Cranial Straight 15mm St — Bien-Air Surgery SA
- Bur Cranial Straight 25 mm St — Bien-Air Surgery SA
- HS Craniotome Burr, long 80k — Bien-Air Surgery SA
- HS Craniotome Burr, medium, 80k — Bien-Air Surgery SA
- HS Craniotome Burr, short, 80k — Bien-Air Surgery SA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bien-Air Surgery SA
Sources (2)
- FDA UDI 6c162d90-d95f-4c7b-b8d7-59dc1cb8ceb4 34 fields · synced Jun 18, 2026
- EUDAMED 8653f33b-d781-41b6-a2ba-91f15e31fca1 61 fields · synced Jun 18, 2026