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
- J00717003020011 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
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
S120 Shaver + Cable by Bien-Air Surgery SA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 bfbe9cad-7bc7-4359-82fb-2bc36b8201bf 34 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 29, 2026