FDA.reportPublic FDA data

Linkt

Primary DI
00810146163923
Brand
Linkt
Company
TRAX SURGICAL INC.
Model
SK12
Catalog number
SK12
Device description
Linkt Staple Instrument Kit - 12mm
Published
2025-06-30
Public version status
New
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810146163923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810146163923008101461639238101461639230810146163923

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119400763
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810146164340Redifix72422724222026-07-20
00810146164357Redifix72425724252026-07-20
00810146164388Redifix72428724282026-07-20
00810146164418Redifix72431724312026-07-20
00810146164449Redifix72434724342026-07-20
00810146164456Redifix72435724352026-07-20
00810146164463Redifix72436724362026-07-20
00810146164500Redifix72440724402026-07-20
00810146164517Redifix72441724412026-07-20
00810146164531Redifix72443724432026-07-20
00810146164562Redifix72446724462026-07-20
00810146164579Redifix72447724472026-07-20
00810146164623Redifix72452724522026-07-20
00810146164654Redifix72455724552026-07-20
00810146164685Redifix72458724582026-07-20
00810146164692Redifix72459724592026-07-20
00810146164715Redifix72462724622026-07-20
00810146160106Trax SurgicalACC-LACC-L2025-06-30
00810146160113Trax SurgicalACC-MACC-M2025-06-30
00810146160120Trax SurgicalACC-SACC-S2025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160543733HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543757HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543788HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543795HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10198956569805CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956603806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956603936CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956607811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956612433CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956612556CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956615465CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956620728CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956620919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621183CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621350CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621640CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956623156CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956623330CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624146CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624276CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624368CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625358CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625747CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625846CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956626010CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
B098AMS18754A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-11-02
B098AMS18911A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-11-02
10809160542309HalyardAVID MEDICAL, INC.OJH2026-10-31
B098AMS14091A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-30
B098AMS200760Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-30