ShBur Straight cyl Ø3.1mm St 1600576-003

GUDID 27630055505471

Bien-Air Surgery SA

ENT suction dissector
Primary Device ID27630055505471
NIH Device Record Keya4574064-77ad-4b72-b4fa-393e5298b5cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameShBur Straight cyl Ø3.1mm St
Version Model Number1600576
Catalog Number1600576-003
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
GS117630055505474 [Primary]
GS127630055505471 [Package]
Contains: 17630055505474
Package: Box [3 Units]
In Commercial Distribution

FDA Product Code

NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-27
Device Publish Date2023-02-17

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