Bur PM2-70 80K Diam Ø2.7 St 1100371-001

GUDID 17630055503371

Bien-Air Surgery SA

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Primary Device ID17630055503371
NIH Device Record Key2e5fc041-0c6a-4be4-9368-4dd26246f533
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-70 80K Diam Ø2.7 St
Version Model Number1100371
Catalog Number1100371-001
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
GS117630055503371 [Primary]
HIBCCJ00711003710011 [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 Ø2.7 St]

176300555033711100371
276300555158141101222

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