Identity
- Trade Name
- Bur PM2-70 cranial straight 25mm sterile FDA UDI
- Generic Name
- Cranial bur, single-use FDA UDI
- Model / Reference
- 1100414 FDA UDI
Identifiers
- Catalog Number
- 1100414-001 FDA UDI
- Primary DI / UDI-DI
- J00711004140011 FDA UDI
- 510(k) Number
- K173066 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Cranial bur, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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 cranial straight 25mm sterile by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K173066 also covers:
- Bur Cranial Spiral 10mm St — Bien-Air Surgery SA
- Bur Cranial Spiral 15mm St — Bien-Air Surgery SA
- Bur Cranial Spiral 25mm St — Bien-Air Surgery SA
- Bur Cranial Straight 10mm St — Bien-Air Surgery SA
- Bur Cranial Straight 15mm St — Bien-Air Surgery SA
- Bur Cranial Straight 25 mm St — Bien-Air Surgery SA
- Cable for Perforator Motor — Bien-Air Surgery SA
- HS Craniotome Burr, long 80k — Bien-Air Surgery SA
- HS Craniotome Burr, medium, 80k — Bien-Air Surgery SA
- HS Craniotome Burr, short, 80k — Bien-Air Surgery SA
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 b05206cb-dc1f-487e-a3f9-82b20eeb50a4 35 fields · synced May 29, 2026