Bur PM2-70 80K diam Ø0.6 St 1101216-001

GUDID 17630055515756

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID17630055515756
NIH Device Record Key8a5fdd27-794d-439a-8515-4bd1b557a59c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-70 80K diam Ø0.6 St
Version Model Number1101216
Catalog Number1101216-001
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 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
GS117630055515756 [Primary]
GS127630055515753 [Package]
Package: Box [1 Units]
In Commercial Distribution

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 Date2024-04-09
Device Publish Date2024-04-01

On-Brand Devices [Bur PM2-70 80K diam Ø0.6 St]

276300555033161100365
176300555157561101216

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