Bur PM2-125 80K diamond Ø1.0mm sterile 1100308-001

GUDID J00711003080011

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device IDJ00711003080011
NIH Device Record Keyc908dc85-7f78-49f3-a2ea-70bb626a0817
Commercial Distribution Discontinuation2023-02-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBur PM2-125 80K diamond Ø1.0mm sterile
Version Model Number1100308
Catalog Number1100308-001
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 Datefalse
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
HIBCCJ00711003080011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-02-09
Device Publish Date2019-01-01

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