FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160051177
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
WINN103-01_0004
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160051174PackageGS13In Commercial Distribution
10809160051177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916005117420809160051174
1080916005117710809160051177

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic cystonephroscopeAn endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. It is inserted into the urethra through the natural urinary orifice, and percutaneously into the renal pelvis for the kidneys during an endoscopic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal/crushing of stones, pyelitis, and renal failure (nephroscopy); and treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence (cystoscopy). This is a reusable device.

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
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
10809160541548HalyardVAPX008-09_0018VAPX008-092026-10-26
10809160541555HalyardVAPX007-09_0021VAPX007-092026-10-26
10809160541562HalyardVAPX012-07_0009VAPX012-072026-10-26
10809160541579HalyardVAPX014-08_0012VAPX014-082026-10-26
10809160541586HalyardVAPX015-12_0016VAPX015-122026-10-26
10809160541593HalyardSAMM021-12_0008SAMM021-122026-10-26
10809160541609HalyardUSAR042-23_0002USAR042-232026-10-26
10809160541616HalyardVAPX013-06_0013VAPX013-062026-10-26
10809160541623HalyardVAPX018-12_0014VAPX018-122026-10-26
10809160541630HalyardVAPX019-07_0029VAPX019-072026-10-26
10809160541647HalyardVAPX020-09_0020VAPX020-092026-10-26
10809160541654HalyardVAPX022-06_0021VAPX022-062026-10-26
10809160541661HalyardVAPX019-07_0001VAPX019-072026-10-26
10809160541678HalyardVAPX036-07_0027VAPX036-072026-10-26
10809160541685HalyardVAPX035-06_0016VAPX035-062026-10-26
10809160541692HalyardVAPX125-06_0017VAPX125-062026-10-26
10809160541708HalyardDNUR81_0007DNUR812026-10-26
10809160541715HalyardVAPX126-02_0019VAPX126-022026-10-26
10809160541340HalyardMMBF002-03_0006MMBF002-032026-10-23
10809160541357HalyardVATX010-15_0013VATX010-152026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956515376CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956577282CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956578869CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956590359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956592902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956596214CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956603752CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956613256CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616646CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616745CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616776CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956617612CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956621961CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956626287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10809160541548HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541586HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541609HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541623HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541630HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541647HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541654HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541661HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541678HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541685HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541692HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541708HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541715HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541760HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-26
B098AMS10429D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-26