ShBlade 40°Convx Ø4.0mm DS St 1600559-005

GUDID 27630055505389

Bien-Air Surgery SA

ENT suction dissector
Primary Device ID27630055505389
NIH Device Record Key91ca4447-4033-4b09-b87b-fd74abf4ca30
Commercial Distribution StatusIn Commercial Distribution
Brand NameShBlade 40°Convx Ø4.0mm DS St
Version Model Number1600559
Catalog Number1600559-005
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
GS117630055505382 [Primary]
GS127630055505389 [Package]
Contains: 17630055505382
Package: Box [5 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

Devices Manufactured by Bien-Air Surgery SA

17630055513752 - Bur PM2-150 80K Steel Ø4.0 St2024-12-12
17630055513769 - Bur PM2-150 80K Steel Ø3.1 St2024-12-12
17630055513783 - Bur PM2 80K Steel TD Ø1.1x5 St2024-12-12
17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St2024-12-12
17630055513813 - Bur Cranial Straight 25 mm St2024-12-12
17630055513820 - Bur Cranial Spiral 25mm St2024-12-12
17630055513837 - Bur Cranial Spiral 10mm St2024-12-12
17630055513844 - Bur Cranial Straight 10mm St2024-12-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.