Bur PM2-150 80K Diam Ø1.0 St 1100329-001

GUDID 27630055503002

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID27630055503002
NIH Device Record Key73e528fd-5e2b-4a95-811c-71f5d18c74cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-150 80K Diam Ø1.0 St
Version Model Number1100329
Catalog Number1100329-001
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
GS117630055503005 [Primary]
GS127630055503002 [Package]
Contains: 17630055503005
Package: Box [1 Units]
In Commercial Distribution
HIBCCJ00711003290011 [Previous]

FDA Product Code

HBCMotor, Drill, Electric

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 Ø1.0 St]

276300555030021100329
176300555156951101207

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