Identity
- Trade Name
- S120 Shaver + Cable FDA UDI
- Generic Name
- ENT shaver system handpiece FDA UDI
- Model / Reference
- 1700302 FDA UDI
Identifiers
- Catalog Number
- 1700302-001 FDA UDI
- Primary DI / UDI-DI
- 17630055506075 FDA UDI
- FDA Product Code
- ERL FDA UDINLY FDA UDIEQJ FDA UDI
- GMDN Term
- ENT shaver system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 FDA UDI874.4140 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
Yes
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
Category: ENT shaver system handpiece
S120 Shaver + Cable by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 b842cd63-8070-4345-b690-14bc4d69a5a3 33 fields · synced Jun 8, 2026