0.35mm S2 Mini Perforator Bur

FDA UDI

Class I (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name: 0.35mm S2 Mini Perforator Bur FDA UDI
Generic Name: Middle ear drill bit FDA UDI
Model / Reference: 1502182 FDA UDI

Identifiers

Catalog Number: 1502182-001 FDA UDI
Primary DI / UDI-DI: 17630055504989 FDA UDI
FDA Product Code: EQJ FDA UDI
NLY FDA UDI
ERL FDA UDI
GMDN Term: Middle ear drill bit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4140 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: Middle ear drill bit

0.35mm S2 Mini Perforator Bur by Bien-Air Surgery SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Middle ear drill bit.

Gyrus ACMI — Gyrus Acmi, Inc. · Class I
T.Carb.Micro-Ear-Burr, Ø1.4, 12k — Bien-Air Surgery SA · Class I
Bur OSSEOSTAP Carb Ø0.8 mm St — Bien-Air Surgery SA · Class I
0.7mm S2 Mini Diamond Round Bur — Bien-Air Surgery SA · Class I
0.6mm S2Mini Diamond Round Bur — Bien-Air Surgery SA · Class I
Bur OSSEOSTAP Diam Ø1.8 mm St — Bien-Air Surgery SA · Class I
Bur OSSEOSTAP Diam Ø1.4 mm St — Bien-Air Surgery SA · Class I
0.7mm S2 Mini Carbide Round Bur — Bien-Air Surgery SA · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bien-Air Surgery SA

Sources (1)

FDA UDI cd3f41b2-1f82-49bd-83b6-9437eea92b66 33 fields · synced May 30, 2026