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Bur PM2-95 80K Steel Ø6.0 St

FDA UDI

Class II (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name
Bur PM2-95 80K Steel Ø6.0 St FDA UDI
Generic Name
Metal/carbide ENT bur, single-use FDA UDI
Model / Reference
1100452 FDA UDI

Identifiers

Catalog Number
1100452-001 FDA UDI
Primary DI / UDI-DI
17630055504071 FDA UDI
FDA Product Code
HBE FDA UDI
HBC FDA UDI
NLY FDA UDI
ERL FDA UDI
EQJ FDA UDI
GMDN Term
Metal/carbide 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

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: Metal/carbide ENT bur, single-use

This Bur PM2-95 80K Steel Ø6.0 St, a single-use metal/carbide ENT bur, is designed for incising or removing cartilage and/or bone from the ear, nose, or throat during mastoid surgery, frontal sinus surgery, or facial nerve surgery. It features a small rotary shaft of hard metal (e.g., steel) with fluting or cutting planes, typically used in combination with a power-driven device.

Similar devices

Also classified as Metal/carbide ENT bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bien-Air Surgery SA

Sources (1)

  • FDA UDI 6527f0fc-9ac7-4d7f-81ac-a6e460f3e18b 33 fields · synced Oct 7, 2026