Bur PM2-MIS P160 steel Ø2.0 St 1100678-001

GUDID 17630055512083

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID17630055512083
NIH Device Record Key6e6aad30-70db-43ca-bd61-d6b576fa2b1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-MIS P160 steel Ø2.0 St
Version Model Number1100678
Catalog Number1100678-001
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
GS117630055512083 [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 Date2025-03-31
Device Publish Date2025-03-21

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