FDA.reportPublic FDA data

AWI

Primary DI
06957277202603
Brand
AWI
Company
Apex (Guangzhou) Tools & Orthopedics Co.
Model
209-04
Device description
EXTREMITY/ARMS/LEGS KIT
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06957277202603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06957277202603069572772026036957277202603

GMDN Terms#

Term, Definition table
TermDefinition
Disposable surgical irrigation/aspiration systemA device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529936792
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06957277203150iTool®KQ-07104NTKQ-07104NT2026-05-15
06957277203167iTool®KQ-14104NTKQ-14104NT2026-05-15
06957277203174iTool®KQ-09109NTKQ-09109NT2026-05-15
06957277203181iTool®KQ-09106NTKQ-09106NT2026-05-15
06957277203198iTool®KQ-11109NTKQ-11109NT2026-05-15
06957277203204iTool®KQ-16104NT KQ-16104NT 2026-05-15
06957277203211iTool®SQ-20109NTSQ-20109NT2026-05-15
06957277203228iTool®SQ-20609NTSQ-20609NT2026-05-15
06957277203235iTool®SQ-24109NTSQ-24109NT2026-05-15
06957277203242iTool®SQ-28109NTSQ-28109NT2026-05-15
06957277203112iTool®112-04112-042025-10-31
06957277203129iTool®112-02112-022025-10-31
06957277203136iTool®112-01112-012025-10-31
06957277202610AWI209-062024-03-06
06957277202504AWI209-00-68209-00-682023-08-11
16957277200354AWI209-00-68209-00-682023-08-11
06957277201583AWI210-01210-012022-03-02
06957277201590AWI210-02210-022022-03-02
16957277201580AWI210-01210-012022-03-02
16957277201597AWI210-02210-022022-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471221512De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2026-05-27
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
04050147023826ErbeErbe Elektromedizin GmbHFQH2026-04-01
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
04050147022959ErbeErbe Elektromedizin GmbHFQH2025-10-01
04050147022942ErbeErbe Elektromedizin GmbHFQH2025-09-30
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
03600040955086ElefantColoplast A/SFQH2024-04-05
03600040955116ElefantColoplast A/SFQH2024-04-05
03600040970614ElefantColoplast A/SFQH2024-04-05
03600040970645ElefantColoplast A/SFQH2024-04-05
03600040970676ElefantColoplast A/SFQH2024-04-05
03600040970737ElefantColoplast A/SFQH2024-04-05
03600040970768ElefantColoplast A/SFQH2024-04-05
03600040970799ElefantColoplast A/SFQH2024-04-05
00034197018470Premier Solution Saline Wound WashPremier Brands of America Inc.FQH2024-03-12
00032251985164Family Wellness Saline Wound WashFamily Dollar StoresFQH2024-03-10