FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160062340
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
SETA008_0004
Catalog number
SETA008
Published
2016-09-10
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

Contact Domains#

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
20809160062347PackageGS125In Commercial Distribution
10809160062340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916006234720809160062347
1080916006234010809160062340

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153AVIDComplaints@Owens-Minor.com

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
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527719HalyardKOOT801-03_0002KOOT801-032026-07-22
10809160527726HalyardLDSF0001_0004LDSF00012026-07-22
10809160527733HalyardLDSF0002_0002LDSF00022026-07-22
10809160527740HalyardLDSF0003_0002LDSF00032026-07-22
10809160527597HalyardBPTJ33-01_0006BPTJ33-012026-07-21
10809160527603HALYARDPVHM223-02PVHM223-022026-07-21
10809160527610HALYARDPVHM221-02PVHM221-022026-07-21
10809160527627HalyardHVBM208-02_0005HVBM208-022026-07-21
10809160527634HalyardBPMY56-02BPMY56-022026-07-21
10809160527641HalyardNHJV6000-22_0006NHJV6000-222026-07-21
10809160527658HalyardKOOT800-01_0003KOOT800-012026-07-21
10809160527672HalyardSHND401-05_0010SHND401-052026-07-21
10809160527689HalyardMEEP10-01_0008MEEP10-012026-07-21
10809160527696HalyardHVBM222-02_0003HVBM222-022026-07-21
10809160527702HalyardSGGR61-04_0002SGGR61-042026-07-21
10809160527542HalyardUSAR053-16_0001USAR053-162026-07-20
10809160527559HalyardSAMM034-21_0001SAMM034-212026-07-20
10809160527566HalyardWILF003-24_0004WILF003-242026-07-20
10809160527573HalyardAVMD057_0001AVMD0572026-07-20
10809160527580HalyardSAMM066-18_0001SAMM066-182026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS174900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394280MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10809160527597HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527627HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527641HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527689HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527696HalyardAVID MEDICAL, INC.LRO2026-07-21
B098AMS15342A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS191710Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS192910Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
10198956263611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956333895CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956352261CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956361751CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956372801CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956373938CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956382176CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956387614CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956393677CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20