Bur PM2-MIS D150 Mstick Ø1.8 St 1100502-001

GUDID 17630055506303

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID17630055506303
NIH Device Record Key0612f977-f6b6-4991-92ca-7b5a3f71bb03
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-MIS D150 Mstick Ø1.8 St
Version Model Number1100502
Catalog Number1100502-001
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
GS117630055506303 [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 Date2025-03-31
Device Publish Date2025-03-21

Devices Manufactured by Bien-Air Surgery SA

07630055508072 - PM2-S MIS2025-03-31
17630055508093 - PM2-Nose MIS D1502025-03-31
17630055512601 - PM2-Nose MIS P1602025-03-31
17630055506266 - Bur PM2-MIS D150 steel Ø2.0 St2025-03-31
17630055506273 - Bur PM2-MIS D150 steel Ø3.0 St2025-03-31
17630055506280 - Bur PM2-MIS D150 diam Ø2.0 St2025-03-31
17630055506297 - Bur PM2-MIS D150 diam Ø3.0 St2025-03-31
17630055506303 - Bur PM2-MIS D150 Mstick Ø1.8 St2025-03-31
17630055506303 - Bur PM2-MIS D150 Mstick Ø1.8 St2025-03-31

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