Bur PM2-70 80K diamC Ø1.5 St

GUDID 17630055519518

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID17630055519518
NIH Device Record Key447428c5-a3ee-44c7-9888-c37b9fcc485d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-70 80K diamC Ø1.5 St
Version Model Number1101380
Company DUNS481597719
Company NameBien-Air Surgery SA
Device Count1
DM Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117630055519518 [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 Date2026-02-23
Device Publish Date2026-02-13

Devices Manufactured by Bien-Air Surgery SA

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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