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
10809160536308HalyardVASF101-10_0001VASF101-102026-09-18
10809160536315HalyardVCIH001-03_0001VCIH001-032026-09-18
10809160536322HalyardVASF100-09_0001VASF100-092026-09-18
10809160536339HalyardVAHT027-16_0002VAHT027-162026-09-18
10809160536346HalyardVAHT021-14_0002VAHT021-142026-09-18
10809160536353HalyardVAHT024-14_0001VAHT024-142026-09-18
10809160536360HalyardVAHT011-12_0001VAHT011-122026-09-18
10809160536377HalyardVAHT013-17_0001VAHT013-172026-09-18
10809160536384HalyardVAHT017-07_0001VAHT017-072026-09-18
10809160536391HalyardVAHT028-12_0001VAHT028-122026-09-18
10809160536407HalyardVAHT026-21_0001VAHT026-212026-09-18
10809160536414HalyardVAHT019-18_0001VAHT019-182026-09-18
10809160536421HalyardVAHT016-06_0001VAHT016-062026-09-18
10809160536438HalyardVAHT023-13_0001VAHT023-132026-09-18
10809160536445HalyardVAHT006-13_0001VAHT006-132026-09-18
10809160536452HalyardVAHT031-19_0001VAHT031-192026-09-18
10809160536469HalyardVAHT030-18_0001VAHT030-182026-09-18
10809160536476HalyardVAHT032-22_0001VAHT032-222026-09-18
10809160536483HalyardWRNM042-16_0003WRNM042-162026-09-18
10809160536490HalyardEAMC102-10_0016EAMC102-102026-09-18

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