Bur PM2-70 80K diam Ø3.5 St 1101224-001

GUDID 27630055515838

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID27630055515838
NIH Device Record Keye2b94d6e-efca-46b2-ab18-1ff826556fb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-70 80K diam Ø3.5 St
Version Model Number1101224
Catalog Number1101224-001
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
GS117630055515831 [Primary]
GS127630055515838 [Package]
Contains: 17630055515831
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 Ø3.5 St]

276300555033921100373
276300555158381101224

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