Bur Cranial Spiral 10mm St

FDA UDI

Class II (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name: Bur Cranial Spiral 10mm St FDA UDI
Generic Name: Cranial bur, single-use FDA UDI
Model / Reference: 1101235 FDA UDI

Identifiers

Catalog Number: 1101235-001 FDA UDI
Primary DI / UDI-DI: 17630055513837 FDA UDI
FDA Product Code: HBE FDA UDI
HBC FDA UDI
GMDN Term: Cranial bur, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4310 FDA UDI
882.4360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cranial bur, single-use

Bur Cranial Spiral 10mm St 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

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 2f741895-6f42-42a8-8d86-c28780d478f0 33 fields · synced May 30, 2026