FDA.reportPublic FDA data

Halyard

Primary DI
10809160539316
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
ACTK56-04_0012
Catalog number
ACTK56-04
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10809160539316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053931610809160539316

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device.

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
10809160539507HalyardAVMD020-01_0011AVMD020-012026-10-01
10809160539514HalyardDONS102-02_0001DONS102-022026-10-01
10809160539521HalyardRDLD003-15_0002RDLD003-152026-10-01
10809160539538HalyardSAMT109-11_0003SAMT109-112026-10-01
10809160539545HalyardSHAN430-07_0007SHAN430-072026-10-01
10809160539552HalyardMSMC114-07_0011MSMC114-072026-10-01
10809160539569HalyardDUPR37-02_0002DUPR37-022026-10-01
10809160539385HalyardGBTK48-02_0002GBTK48-022026-09-30
10809160539392HALYARDGBCC47-02GBCC47-022026-09-30
10809160539408HalyardDUEC64-04_0003DUEC64-042026-09-30
10809160539415HalyardHVBM218-03_0003HVBM218-032026-09-30
10809160539422HalyardSOLC12A-01_0001SOLC12A-012026-09-30
10809160539439HalyardHVSP200-05_0003HVSP200-052026-09-30
10809160539446HalyardHVSP212-04_0006HVSP212-042026-09-30
10809160539453HalyardGUGE09-02_0001GUGE09-022026-09-30
10809160539460HalyardMSMC121-03_0001MSMC121-032026-09-30
10809160539477HalyardSTJO002-08_0004STJO002-082026-09-30
10809160539484HalyardMSBM042-08_0006MSBM042-082026-09-30
10809160539491HalyardJACK400-06_0005JACK400-062026-09-30
10809160539217HalyardMMBN007-02_0016MMBN007-022026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956537385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-01
10809160539507HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539514HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539521HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539538HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539552HalyardAVID MEDICAL, INC.LRO2026-10-01
10198956488564CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956513471CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956519565CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956553989CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956558540CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956559486CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956562684CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956567757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956567955CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956568273CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956568341CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570856CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570870CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570986CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956581005CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956581159CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956584921CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956585188CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956592520CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956593381CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956593589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956594241CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956595705CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956598249CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30