Identity
- Trade Name
- S120 Shaver FDA UDI
- Generic Name
- ENT shaver system handpiece FDA UDI
- Model / Reference
- 1600614 FDA UDI
Identifiers
- Catalog Number
- 1600614-001 FDA UDI
- Primary DI / UDI-DI
- J00716006140011 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
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
Moist Heat or Steam Sterilization FDA UDI
S120 Shaver 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 f4149646-4f66-409c-994b-b80cf11b2f3f 34 fields · synced Jun 8, 2026