Identity
- Trade Name
- OSSEODUO Control Unit FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Model / Reference
- 1600513 FDA UDI
Identifiers
- Catalog Number
- 1600513-001 FDA UDI
- Primary DI / UDI-DI
- J00716005130011 FDA UDI
- FDA Product Code
- HBC FDA UDIERL FDA UDI
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4360 FDA UDI874.4250 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
OSSEODUO Control Unit by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 3b860a2d-78b9-4b0d-b3dc-908bc59e889d 34 fields · synced May 31, 2026