Bur PM2-70 80K steel twist drill Ø1.1x4mm sterile 1100472-001

GUDID J00711004720011

Bien-Air Surgery SA

Metal/carbide ENT bur, single-use
Primary Device IDJ00711004720011
NIH Device Record Key33f2fa89-649d-492e-94aa-963abd43fc79
Commercial Distribution Discontinuation2023-02-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBur PM2-70 80K steel twist drill Ø1.1x4mm sterile
Version Model Number1100472
Catalog Number1100472-001
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
HIBCCJ00711004720011 [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 Date2023-02-09
Device Publish Date2019-01-07

Devices Manufactured by Bien-Air Surgery SA

27630055514626 - Bur PM2-70 80K diam C Ø2.3 St2024-04-09
27630055514732 - Bur PM2-70 80K diam C Ø3.1 St2024-04-09
17630055515756 - Bur PM2-70 80K diam Ø0.6 St2024-04-09
17630055515763 - Bur PM2-70 80K diam Ø0.8 St2024-04-09
27630055515777 - Bur PM2-70 80K diam Ø1.0 St2024-04-09
27630055515784 - Bur PM2-70 80K diam Ø1.4 St2024-04-09
27630055515791 - Bur PM2-70 80K diam Ø1.8 St2024-04-09
27630055515807 - Bur PM2-70 80K diam Ø2.3 St2024-04-09

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