Bur PM2-70 80K steel Ø1.5 St

GUDID 17630055519419

Bien-Air Surgery SA

Metal/carbide ENT bur, single-use
Primary Device ID17630055519419
NIH Device Record Key09fb99b4-ae18-4d45-93d9-c043ad27f480
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-70 80K steel Ø1.5 St
Version Model Number1101369
Company DUNS481597719
Company NameBien-Air Surgery SA
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117630055519419 [Primary]

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

Devices Manufactured by Bien-Air Surgery SA

17630055519419 - Bur PM2-70 80K steel Ø1.5 St2026-02-24
17630055519419 - Bur PM2-70 80K steel Ø1.5 St2026-02-24
17630055519525 - Bur PM2-70 80K diam EC Ø4.0x80 St2026-02-24
27630055519539 - Bur PM2-70 80K steel Ø2.0 St2026-02-24
17630055519549 - Bur PM2-70 80K steel Ø2.0x80 St2026-02-24
17630055519556 - Bur PM2-70 80K diam Ø1.5 St2026-02-24
17630055519563 - Bur PM2-70 80K diam Ø1.5x80 St2026-02-24
17630055519570 - Bur PM2-70 80K diam EC Ø5.0x80 St2026-02-24
17630055519587 - Bur PM2-70 80K diamC Ø2.0 St2026-02-24

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