Bur PM2-70 80K Diam Ø5.0 St 1100376-001

GUDID 27630055503422

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device ID27630055503422
NIH Device Record Key289519ed-7ccd-4e23-9fc7-ee106f33f2bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-70 80K Diam Ø5.0 St
Version Model Number1100376
Catalog Number1100376-001
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
GS117630055503425 [Primary]
GS127630055503422 [Package]
Contains: 17630055503425
Package: Box [1 Units]
In Commercial Distribution
HIBCCJ00711003760011 [Previous]

FDA Product Code

HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

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 PM2-70 80K Diam Ø5.0 St]

276300555034221100376
276300555158691101227

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