FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160077573
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
TUFT057-08_0003
Catalog number
TUFT057-08
Published
2016-09-09
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
10809160077573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916007757310809160077573

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
10809160527177HALYARDPVHM213-03PVHM213-032026-07-17
10809160527313HalyardDHOR82-01_0002DHOR82-012026-07-17
10809160527320HalyardWBAM032-12_0001WBAM032-122026-07-17
10809160527337HalyardPVHM225-01PVHM225-012026-07-17
10809160527344HalyardVAPX018-10_0010VAPX018-102026-07-17
10809160527351HalyardBMHT029-02_0002BMHT029-022026-07-17
10809160527368HalyardBMHT031-06_0005BMHT031-062026-07-17
10809160527375HalyardARMC015_0013ARMC0152026-07-17
10809160527382HalyardBMGT003-03_0005BMGT003-032026-07-17
10809160527399HalyardBMGT016-05_0002BMGT016-052026-07-17
10809160527405HalyardBMGT014-04_0003BMGT014-042026-07-17
10809160527412HalyardBMHT031-06_0006BMHT031-062026-07-17
10809160527429HalyardBMHT107-06_0006BMHT107-062026-07-17
10809160527436HalyardMSBM004-06_0008MSBM004-062026-07-17
10809160527443HalyardMSBM006-02_0011MSBM006-022026-07-17
10809160527450HalyardMSBM027-05_0004MSBM027-052026-07-17
10809160527467HalyardBMHT400-02_0011BMHT400-022026-07-17
10809160527474HalyardBMHT401-03_0004BMHT401-032026-07-17
10809160527481HalyardDUPD23-02_0006DUPD23-022026-07-17
10809160527498HalyardWBAM054-02ANC_0003WBAM054-02ANC2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS192900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-19
10809160527177HALYARDAVID MEDICAL, INC.LRO2026-07-17
10809160527313HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527320HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527344HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527351HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527368HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527399HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527405HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527412HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527443HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527450HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527467HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527474HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527481HalyardAVID MEDICAL, INC.LRO2026-07-17
10198956344020CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956418431CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956439887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956444386CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956462175CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956472105CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477391CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956479845CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956483439CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956488304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956502437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956504868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956508149CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16