Identity
- Trade Name
- OSSEODOC Foot Pedal FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Model / Reference
- 1600407 FDA UDI
Identifiers
- Catalog Number
- 1600407-001 FDA UDI
- Primary DI / UDI-DI
- 17630055505207 FDA UDI
- 510(k) Number
- K792159 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
OSSEODOC Foot Pedal by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- 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
- PMAM 1221 125mm — Bien-Air Surgery SA
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
- Bien-Air Surgery SA
Sources (1)
- FDA UDI 8484004c-2fef-4ddb-af2b-ab5f0f90461d 34 fields · synced Jun 1, 2026