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Bur PM2-70 50K Diam C Ø3.1

FDA UDI

Class I (US FDA UDI)

by Bien-Air Surgery SA

Identity

Trade Name
Bur PM2-70 50K Diam C Ø3.1 FDA UDI
Generic Name
Diamond ENT bur, reusable FDA UDI
Model / Reference
1100306 FDA UDI

Identifiers

Catalog Number
1100306-001 FDA UDI
Primary DI / UDI-DI
07630055502797 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 C Ø3.1 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 bd425eb4-7ee8-4ff9-a396-38e02805ffdb 33 fields · synced Jun 1, 2026