Bur PM2-150 80K Diam C Ø5.0 St 1101213-001

GUDID 17630055514728

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID17630055514728
NIH Device Record Key15a0faa4-bee9-4474-8266-3101b022faa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-150 80K Diam C Ø5.0 St
Version Model Number1101213
Catalog Number1101213-001
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 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
GS117630055514728 [Primary]

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-12
Device Publish Date2024-12-04

On-Brand Devices [Bur PM2-150 80K Diam C Ø5.0 St]

276300555030641100335
176300555147281101213

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