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Bur PM2-70 50K Diam Ø2.7

FDA UDI

Class I (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name
Bur PM2-70 50K Diam Ø2.7 FDA UDI
Generic Name
Diamond ENT bur, reusable FDA UDI
Model / Reference
1100253 FDA UDI

Identifiers

Catalog Number
1100253-001 FDA UDI
Primary DI / UDI-DI
07630055502292 FDA UDI
FDA Product Code
EQJ FDA UDI
GMDN Term
Diamond ENT bur, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4140 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Diamond ENT bur, reusable

Bur PM2-70 50K Diam Ø2.7 by Bien-Air Surgery SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diamond ENT bur, reusable.

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 411be4d0-90a0-4bd4-9492-605514f63756 33 fields · synced May 30, 2026