Bur PM2-70 80K Diam Ø2.3 St

FDA UDI

Class II (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name: Bur PM2-70 80K Diam Ø2.3 St FDA UDI
Generic Name: Diamond ENT bur, single-use FDA UDI
Model / Reference: 1100370 FDA UDI

Identifiers

Catalog Number: 1100370-001 FDA UDI
Primary DI / UDI-DI: 17630055503364 FDA UDI
FDA Product Code: HBE FDA UDI
HBC FDA UDI
NLY FDA UDI
ERL FDA UDI
EQJ FDA UDI
GMDN Term: Diamond ENT bur, single-use FDA UDI

Classification

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

Bur PM2-70 80K Diam Ø2.3 St by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 e5301471-de38-42c6-86f7-72ce0e384cab 33 fields · synced May 31, 2026