FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160050542
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
KPSC007-06_0003
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
20809160050542PackageGS13In Commercial Distribution
10809160050545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916005054220809160050542
1080916005054510809160050545

GMDN Terms#

Term, Definition table
TermDefinition
Podiatry kit, single-useA collection of devices intended for treatment of cutaneous foot disorders such as hardened skin, corns, and ingrown/ingrowing toenails. It typically consists of two or more of the following items: nail cutters, nail file, dermal curette, scalpel handle and blades, probe, gauze applicators, and/or dressings (e.g., coverings, protection/treatment solutions); it may be used in the home and healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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