Bur PM2-95 80K matchstick Ø1.8mm sterile 1100336-001

GUDID J00711003360011

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device IDJ00711003360011
NIH Device Record Keya158fba9-2131-484c-9112-c088da2e301f
Commercial Distribution Discontinuation2023-02-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBur PM2-95 80K matchstick Ø1.8mm sterile
Version Model Number1100336
Catalog Number1100336-001
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00711003360011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-02-09
Device Publish Date2019-01-08

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