FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160034798
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
MIHS003-01_0001
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

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
20809160034795PackageGS115In Commercial Distribution
10809160034798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916003479520809160034795
1080916003479810809160034798

GMDN Terms#

Term, Definition table
TermDefinition
External facial prosthesisAn externally-applied device intended to be used as an artificial substitute for two or more sections of the face [typically eye(s) and/or nose and surrounding regions (e.g., eye brows, forehead, midface)] to help restore facial appearance. The device is customized to meet the patient's needs and may be held in position with magnets or screw-like implants embedded into the patient's facial bone. It is used in cases of severe facial disfigurement typically caused by trauma (e.g., gunshot wounds) or major facial cancer surgery.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
10809160523063HalyardSFSLVTJ65-01_0001SFSLVTJ65-012026-06-09
10809160523070HalyardLVTJ65-01_0011LVTJ65-012026-06-09
10809160523087HalyardSFSMSBM022-06_0003SFSMSBM022-062026-06-09
10809160523094HalyardAXOG2000-11_0001AXOG2000-112026-06-09
10809160523100HalyardACTK56-03_0009ACTK56-032026-06-09
10809160523117HalyardSGGY67-05_0003SGGY67-052026-06-09
10809160523124HalyardBMHT020-05_0001BMHT020-052026-06-09
10809160523131HalyardSHAN409-06_0004SHAN409-062026-06-09
10809160523148HalyardAMCH001-02_0002AMCH001-022026-06-09
10809160523162HalyardDUCD44-03_0003DUCD44-032026-06-09
10809160523179HalyardLLHT24-01_0006LLHT24-012026-06-09
10809160523186HalyardLMCV54-01_0002LMCV54-012026-06-09
10809160523193HalyardUICD62-01_0004UICD62-012026-06-09
10809160523209HalyardRCOH61-01_0007RCOH61-012026-06-09
10809160523216HalyardUICS88-01_0002UICS88-012026-06-09
10809160523223HalyardUIPD03-01_0005UIPD03-012026-06-09
10809160523230HalyardWILF002-23_0005WILF002-232026-06-09
10809160523247HalyardWILF002-23_0006WILF002-232026-06-09
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160523063HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523070HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523094HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523100HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523124HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523131HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523223HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523230HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523247HalyardAVID MEDICAL, INC.LRO2026-06-09
10197106911266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956359024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956364783CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956429666CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956432048CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956433144CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956443518CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956466012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956467484CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469204CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956473423CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477292CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477339CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483378CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483903CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956484368CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956487406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956492660CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956493667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08