Bur PM2-95 80K matchstick Ø3.0mm sterile 1100337-001

GUDID J00711003370011

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device IDJ00711003370011
NIH Device Record Keyf62b07e5-2011-4baa-a696-00bfcd20bdc3
Commercial Distribution Discontinuation2023-02-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBur PM2-95 80K matchstick Ø3.0mm sterile
Version Model Number1100337
Catalog Number1100337-001
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 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
HIBCCJ00711003370011 [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

Devices Manufactured by Bien-Air Surgery SA

17630055519426 - Bur PM2-70 80K steel Ø1.5x80 St2026-02-23
17630055519433 - Bur PM2-125 80K steel Ø1.5 St2026-02-23
17630055519440 - Bur PM2-70 80K diam EC Ø2.5x80 St2026-02-23
17630055519457 - Bur PM2-70 80K diam EC Ø3.0x80 St2026-02-23
17630055519464 - Bur PM2-70 80K diam EC Ø3.5x80 St2026-02-23
17630055519471 - Bur PM2-70 80K diamC Ø1.0x80 St2026-02-23
17630055519488 - Bur PM2-70 80K FC Ø2.5 St2026-02-23
17630055519495 - Bur PM2-70 80K diamC Ø1.5x80 St2026-02-23

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.