Bur PM2-95 80K drum coarse Ø4.0x8mm sterile 1100338-001

GUDID J00711003380011

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device IDJ00711003380011
NIH Device Record Key80fe3e20-1974-42b4-a376-da9ae62be5df
Commercial Distribution Discontinuation2023-02-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBur PM2-95 80K drum coarse Ø4.0x8mm sterile
Version Model Number1100338
Catalog Number1100338-001
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
HIBCCJ00711003380011 [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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