HS Diam. Burr, Ø3.1x95, 80k

FDA UDI

Class I (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name: HS Diam. Burr, Ø3.1x95, 80k FDA UDI
Generic Name: Diamond ENT bur, single-use FDA UDI
Model / Reference: 360231 S FDA UDI

Identifiers

Catalog Number: 1100575-001 FDA UDI
Primary DI / UDI-DI: 17630055507164 FDA UDI
FDA Product Code: EQJ FDA UDI
HBC FDA UDI
HBE FDA UDI
NLY FDA UDI
ERL FDA UDI
GMDN Term: Diamond ENT bur, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4140 FDA UDI
882.4360 FDA UDI
882.4310 FDA UDI
874.4250 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: Diamond ENT bur, single-use

HS Diam. Burr, Ø3.1x95, 80k by Bien-Air Surgery SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
Invotec ENT Bur — Invotec International, Inc. · Class I
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OSSEOUS Burs-Fine Diamond — EON MEDITECH PRIVATE LIMITED · 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 e00f4f36-b9b9-4539-a526-ed15e32d94d9 33 fields · synced Jun 8, 2026