iTool® APEXPULSE™ 201-03-00

GUDID 16972130470026

Disposable Pulse Lavage Knee Kit

Apex (Suzhou) Medical Products Company

Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system
Primary Device ID16972130470026
NIH Device Record Keyddd8280d-99a7-4bb0-8079-fcd32e05df29
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTool® APEXPULSE™
Version Model Number201-03-00
Catalog Number201-03-00
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 Datetrue
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
GS116972130470026 [Primary]
GS116972130470026 [Primary]
GS116972130470026 [Primary]
GS116972130470026 [Primary]
GS116972130470026 [Primary]

FDA Product Code

FQHLavage, Jet
FQHLavage, Jet
FQHLavage, Jet
FQHLavage, Jet
FQHLavage, Jet

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-06
Device Publish Date2020-10-29

On-Brand Devices [iTool® APEXPULSE™]

06972130470029Disposable Pulse Lavage Knee Kit
06972130470012Disposable Pulse Lavage Component Kit
16972130470026Disposable Pulse Lavage Knee Kit

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.