Identity
- Trade Name
- Set OSSEOSTAP Burs 6pcs FDA UDI
- Generic Name
- Middle ear drill bit FDA UDI
- Model / Reference
- 1700332 FDA UDI
Identifiers
- Catalog Number
- 1700332-001 FDA UDI
- Primary DI / UDI-DI
- 17630055506099 FDA UDI
- FDA Product Code
- EQJ FDA UDI
- GMDN Term
- Middle ear drill bit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4140 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Middle ear drill bit
Set OSSEOSTAP Burs 6pcs by Bien-Air Surgery SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Middle ear drill bit.
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- 0.7mm S2 Mini Carbide Round Bur — Bien-Air Surgery SA · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Surgery SA
Sources (1)
- FDA UDI 79c889bd-d837-4340-9c99-af805ac5f4ef 33 fields · synced May 31, 2026