FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160051313
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
LAKC013-06_0003
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
20809160051310PackageGS13In Commercial Distribution
10809160051313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916005131020809160051310
1080916005131310809160051313

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar decompression procedure kitA collection of sterile devices used to perform percutaneous, minimally-invasive lumbar decompression (MILD) for the treatment of various spine conditions, typically in conjunction with an endoscope. It typically includes trocars, cannulae (portals), a retractor, and other essential materials for the procedure; it may also include a disposable endoscope. It is used for image-guided tissue resection of the lumbar spine involving retraction, grasping, cutting, ablation, and coagulation of the spinal tissues. This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160528112HalyardSAMM041-08_0001SAMM041-082026-07-30
10809160528129HalyardNAMC434-09_0002NAMC434-092026-07-30
10809160528136HalyardNAFB062-09_0001NAFB062-092026-07-30
10809160528143HalyardGBEY17-02_0011GBEY17-022026-07-30
10809160528150HalyardPVHM222-02_0005PVHM222-022026-07-30
10809160528167HalyardSBHT00-06_0001SBHT00-062026-07-30
10809160528174HalyardDONS101-02_0001DONS101-022026-07-30
10809160528181HalyardQCEORSP123_0001QCEORSP1232026-07-30
10809160528198HalyardVMLR032-04_0005VMLR032-042026-07-30
10809160528051HalyardBPTJ33-01_0016BPTJ33-012026-07-29
10809160528075HalyardBMHT301-02_0007BMHT301-022026-07-29
10809160528082HalyardWINN121-11_0004WINN121-112026-07-29
10809160528099HalyardJCSP60F_0011JCSP60F2026-07-29
10809160528105HalyardESEY90-03_0016ESEY90-032026-07-29
10809160527856HalyardAVMD054_0004AVMD0542026-07-28
10809160527863HalyardAVMD052-02_0004AVMD052-022026-07-28
10809160527870HALYARDPVHM201-02PVHM201-022026-07-28
10809160527887HALYARDPVHM205-02PVHM205-022026-07-28
10809160527894HalyardOGDV68-02OGDV68-022026-07-28
10809160527900HalyardUPVD01-02UPVD01-022026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528112HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528136HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528174HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528181HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528198HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528051HalyardAVID MEDICAL, INC.LRO2026-07-29
10809160528099HalyardAVID MEDICAL, INC.LRO2026-07-29
10653160393511CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-28
10809160527955HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527962HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527993HalyardAVID MEDICAL, INC.LRO2026-07-28
10809160528044HalyardAVID MEDICAL, INC.LRO2026-07-28
10197106838556CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956355385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956359512CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956371965CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956384927CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956390102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956392885CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956393196CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956394735CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956400900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956401129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956406544CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956410268CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956423817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956443136CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445932CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956457829CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27