Identity
- Trade Name
- Bur PM2-70 80K steel Ø7.0mm sterile FDA UDI
- Generic Name
- Metal/carbide ENT bur, single-use FDA UDI
- Model / Reference
- 1100364 FDA UDI
Identifiers
- Catalog Number
- 1100364-001 FDA UDI
- Primary DI / UDI-DI
- J00711003640011 FDA UDI
- FDA Product Code
- EQJ FDA UDIHBE FDA UDI
- GMDN Term
- Metal/carbide ENT bur, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4140 FDA UDI882.4310 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bur PM2-70 80K steel Ø7.0mm sterile by Bien-Air Surgery SA — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Surgery SA
Sources (1)
- FDA UDI e1a324c1-7182-4226-9291-1187d360e446 34 fields · synced Jun 8, 2026