FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160209585
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
VAML034-06_0003
Catalog number
VAML034-06
Published
2018-09-14
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
20809160209582PackageGS13In Commercial Distribution
10809160209585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916020958220809160209582
1080916020958510809160209585

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.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160529188HalyardGBTK48-02_0005GBTK48-022026-08-07
10809160529195HalyardBKLS53-02_0004BKLS53-022026-08-07
10809160529201HalyardSGRB86-05_0011SGRB86-052026-08-07
10809160529218HalyardSGCB55-05_0001SGCB55-052026-08-07
10809160529225HalyardVMCC024-14_0008VMCC024-142026-08-07
10809160529232HalyardAKML42-02_0014AKML42-022026-08-07
10809160529249HalyardQPLP65-02_0004QPLP65-022026-08-07
10809160529256HalyardSFSAKML42-02_0001SFSAKML42-022026-08-07
10809160529263HalyardAKLE90-03_0002AKLE90-032026-08-07
10809160529270HalyardSFSAKLE90-03_0001SFSAKLE90-032026-08-07
10809160529287HalyardQPMN13-02_0011QPMN13-022026-08-07
10809160529294HalyardACTS62-02_0004ACTS62-022026-08-07
10809160529300HalyardACSH43-04_0002ACSH43-042026-08-07
10809160529317HalyardHVBM213-04_0004HVBM213-042026-08-07
10809160529324HalyardBMHT501-01_0011BMHT501-012026-08-07
10809160529331HalyardJACK428-07_0004JACK428-072026-08-07
10809160529348HalyardMSBM039-04_0004MSBM039-042026-08-07
10809160529355HalyardMCLP78-02_0007MCLP78-022026-08-07
10809160529362HalyardSELF134-05_0007SELF134-052026-08-07
10809160529379HalyardSELF133-07_0004SELF133-072026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160529447HalyardAVID MEDICAL, INC.LRO2026-08-08
10809160529188HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529195HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529201HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529225HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529232HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529249HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529256HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529263HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529270HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529287HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529294HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529300HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529317HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529324HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529348HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529355HalyardAVID MEDICAL, INC.LRO2026-08-07
10885632529412SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529429SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529436SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03