Bur PM2-150 80K Diam C Ø3.1 St 1100333-001

GUDID 27630055503040

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID27630055503040
NIH Device Record Keyf9b89254-4fb8-4420-a5dd-202c08fa3020
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-150 80K Diam C Ø3.1 St
Version Model Number1100333
Catalog Number1100333-001
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
GS117630055503043 [Primary]
GS127630055503040 [Package]
Contains: 17630055503043
Package: Box [1 Units]
In Commercial Distribution
HIBCCJ00711003330011 [Previous]

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 Date2023-02-16
Device Publish Date2023-02-08

On-Brand Devices [Bur PM2-150 80K Diam C Ø3.1 St]

276300555030401100333
176300555147041101211

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