Bur PM2-70 80K Matchstick Ø1.8mm sterile 1100460-001

GUDID J00711004600011

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device IDJ00711004600011
NIH Device Record Keydb4aa09e-14c7-4dfd-bc7d-3fc749867fb2
Commercial Distribution Discontinuation2023-02-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBur PM2-70 80K Matchstick Ø1.8mm sterile
Version Model Number1100460
Catalog Number1100460-001
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
HIBCCJ00711004600011 [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 Number2
Public Version Date2023-02-10
Device Publish Date2019-01-07

Devices Manufactured by Bien-Air Surgery SA

17630055513752 - Bur PM2-150 80K Steel Ø4.0 St2024-12-12
17630055513769 - Bur PM2-150 80K Steel Ø3.1 St2024-12-12
17630055513783 - Bur PM2 80K Steel TD Ø1.1x5 St2024-12-12
17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St2024-12-12
17630055513813 - Bur Cranial Straight 25 mm St2024-12-12
17630055513820 - Bur Cranial Spiral 25mm St2024-12-12
17630055513837 - Bur Cranial Spiral 10mm St2024-12-12
17630055513844 - Bur Cranial Straight 10mm St2024-12-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.