Identity
- Trade Name
- HS Craniotome Burr, short, 80k FDA UDI
- Generic Name
- Cranial bur, single-use FDA UDI
- Model / Reference
- 362640 S FDA UDI
Identifiers
- Catalog Number
- 1100605-001 FDA UDI
- Primary DI / UDI-DI
- 17630055507461 FDA UDI
- 510(k) Number
- K173066 FDA UDI
- FDA Product Code
- HBE FDA UDIHBC FDA UDI
- GMDN Term
- Cranial bur, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 FDA UDI882.4360 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Category: Cranial bur, single-use
HS Craniotome Burr, short, 80k by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur, single-use.
- HiCUT Burs — adeor Medical AG · Class II
- Disposable Sterile Vessel Punch — Zibo MK Medical Technology Co., Ltd. · Class IIa
- PDS-2RDUL-15 — NAKANISHI INC. · Class IIa
- GT PODO 7 mm spitz/pointed Schaft 2, 35 X 40 — LUKAS-ERZETT GmbH & Co.KG · Class I
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- J-Notch Burs — Stryker Instruments · Class IIa
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- GT PODO 5 mm rund/round Schaft 2, 35 x 35 — LUKAS-ERZETT GmbH & Co.KG · Class I
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
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 572f7ed8-39ca-4b4c-bea9-4bafdfeb6b79 34 fields · synced May 31, 2026