Bur PM2-70 80K diam Ø1.0 St 1101218-001

GUDID 27630055515777

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID27630055515777
NIH Device Record Key70cfb0c6-59a8-40af-b431-0049e554cc2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-70 80K diam Ø1.0 St
Version Model Number1101218
Catalog Number1101218-001
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
GS117630055515770 [Primary]
GS127630055515777 [Package]
Contains: 17630055515770
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 Ø1.0 St]

276300555033301100367
276300555157771101218

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