AWI 236-00

GUDID 06972130470531

Disposable Pulse Irrigation Kit

Apex (Suzhou) Medical Products Company

Disposable surgical irrigation/aspiration system
Primary Device ID06972130470531
NIH Device Record Keya9a472d0-a00f-41be-bab0-f8ad835b783f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAWI
Version Model Number236-00
Catalog Number236-00
Company DUNS554507451
Company NameApex (Suzhou) Medical Products Company
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972130470531 [Primary]

FDA Product Code

FQHLavage, Jet

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [AWI]

26972130470436Disposable Pulse Irrigation Kit
06972130470418Hydra Adaptor
06972130470401Tunnel Tip
06972130470395Disposable Irrigation Bag(Apply to Trunk-L)
06972130470388Disposable Irrigation Bag(Apply to Extremity)
16972130470439Disposable Pulse Irrigation Kit
16972130470422Standard Tip
06972130470432Disposable Pulse Irrigation Kit
06972130470425Standard Tip
26972130470511Disposable Pulse Irrigation Kit
06972130470517Disposable Pulse Irrigation Kit
06972130470500Standard Tip
16972130470507Standard Tip
16972130470491Hydra Adaptor
16972130470484Tunnel Tip
16972130470477Disposable Irrigation Bag(Apply to Trunk-L)
16972130470460Disposable Irrigation Bag(Apply to Extremity)
16972130470514Disposable Pulse Irrigation Kit
26972130470535Disposable Pulse Irrigation Kit
16972130470538Disposable Pulse Irrigation Kit
06972130470531Disposable Pulse Irrigation Kit

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