AWI

GUDID 06957277202603

EXTREMITY/ARMS/LEGS KIT

Apex (Guangzhou) Tools & Orthopedics Co.

Disposable surgical irrigation/aspiration system
Primary Device ID06957277202603
NIH Device Record Key1ab10aa8-3e83-471e-bbd4-480ecbac09eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAWI
Version Model Number209-04
Company DUNS529936792
Company NameApex (Guangzhou) Tools & Orthopedics Co.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS106957277202603 [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 Date2024-03-14
Device Publish Date2024-03-06

On-Brand Devices [AWI]

06957277200692PULSE IRRIGATOR
06957277200449HYDRA ADAPTOR
06957277200371STANDARD TIP
06957277200364STANDARD TIP
06957277200357STANDARD TIP
06957277200340TUNNEL TIP
06957277200333PULSE IRRIGATOR
06957277200326PULSE IRRIGATOR
16957277200804TRUNK-S IRRIGATION BAG
06957277200814TRUNK-S IRRIGATION BAG
16957277200774TRUNK-L IRRIGATION KIT
06957277200784TRUNK-L IRRIGATION KIT
16957277200743TRUNK-S IRRIGATION KIT
06957277200753TRUNK-S IRRIGATION KIT
16957277200712EXTREMITY IRRIGATION KIT
06957277200722EXTREMITY IRRIGATION KIT
16957277200682PULSE IRRIGATOR WITH HYDRA ADAPTOR
16957277201597TRUNK IRRIGATION BAG
16957277201580EXTREMITY IRRIGATION BAG
16957277200354STANDARD TIP
06957277202610SACRAL/TRUNK/BODY KIT
06957277202603EXTREMITY/ARMS/LEGS KIT
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.