FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160060971
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
STJO003_0001
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LJHSystem, irrigation, urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJHSystem, Irrigation, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023808000IRRIGATION SETSInternational Medsurg Connection2003-03-10LJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160060978PackageGS1100In Commercial Distribution
10809160060971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916006097820809160060978
1080916006097110809160060971

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160531853HalyardDGAL24-03_0010DGAL24-032026-08-27
10809160531860HalyardDGBB41-02_0006DGBB41-022026-08-27
10809160531877HalyardDGIV63_0008DGIV632026-08-27
10809160531884HalyardDUAD22-01_0004DUAD22-012026-08-27
10809160531891HalyardDUCC54_0009DUCC542026-08-27
10809160531907HalyardDUEC27-01_0004DUEC27-012026-08-27
10809160531914HalyardSJGH109-07_0007SJGH109-072026-08-27
10809160531921HalyardSFSEURO028-07_0001SFSEURO028-072026-08-27
10809160531938HalyardSHND415-02_0001SHND415-022026-08-27
10809160531945HalyardSOTJ41-01_0007SOTJ41-012026-08-27
10809160531952HalyardNAMC425-08_0013NAMC425-082026-08-27
10809160531969HalyardWAFB224-03_0007WAFB224-032026-08-27
10809160531976HalyardSFSBAAK106-15_0001SFSBAAK106-152026-08-27
10809160531983HalyardSFSEABF007-15_0001SFSEABF007-152026-08-27
10809160531990HalyardSFSBUAH026-24_0001SFSBUAH026-242026-08-27
10809160532003HalyardSFSEAMC114-07_0001SFSEAMC114-072026-08-27
10809160532010HalyardWRNM004-18_0004WRNM004-182026-08-27
10809160532027HalyardEURO002-11_0005EURO002-112026-08-27
10809160532034HalyardSFSEURO010-10_0001SFSEURO010-102026-08-27
10809160532041HalyardEURO013-11_0005EURO013-112026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.LJH2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.LJH2026-05-05
10704411021544AMSure® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2026-04-10
00191506023348Asurys™BOSTON SCIENTIFIC CORPORATIONLJH2026-04-03
00191506047962Asurys™BOSTON SCIENTIFIC CORPORATIONLJH2026-04-03
10704411016090AMSure ® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
10704411016106AMSure ® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
40704411016091AMSure ® Four Lead Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
40704411016107AMSure ® Cystoscopy/Bladder Irrigation SetAMSINO INTERNATIONAL, INC.LJH2023-04-13
10080196993819MEDLINEMEDLINE INDUSTRIES, INC.LJH2020-11-12
10080196993826MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
10080196993833MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
40080196993810MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
40080196993834MedlineMEDLINE INDUSTRIES, INC.LJH2020-11-12
00628725001012MED-RXCanadian Hospital Specialties LimitedLJH2016-10-19
00628725001043MED-RXCanadian Hospital Specialties LimitedLJH2016-10-18
00628725001050MED-RXCanadian Hospital Specialties LimitedLJH2016-10-18
10884389942604MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10884389942611MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10884389942628MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
00817183020363Flo-Assist IINORTHGATE TECHNOLOGIES INC.LJH2016-10-14
40884389942605MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
40884389942612MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
40884389942629MedlineMEDLINE INDUSTRIES, INC.LJH2016-10-14
10817183020360Flo-Assist IINORTHGATE TECHNOLOGIES INC.LJH2016-10-14
00085412000978Arthromatic/UromaticBAXTER INTERNATIONAL INC.LJH2016-09-24
00085412000985Arthromatic/UromaticBAXTER INTERNATIONAL INC.LJH2016-09-24
00085412001005Arthromatic/UromaticBAXTER INTERNATIONAL INC.LJH2016-09-24
00085412001029NABAXTER INTERNATIONAL INC.LJH2016-09-24