FDA.report

Halyard

Primary DI
20809160383534
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
AHAR21L_0007
Catalog number
AHAR21L
Published
2022-09-03
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

Related Records

Contact Domains

Product Codes

CodeName
LROGeneral surgery tray

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160383534PackageGS13In Commercial Distribution
10809160383537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916038353420809160383534
1080916038353710809160383537

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

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 DIBrandModelCatalogPublished
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
20809160517236HalyardDRRD48-02_0004DRRD48-022026-03-24
20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
20809160517250HalyardUSAR017-12_0006USAR017-122026-03-24
20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23
20809160517182HalyardOSTK19-01_0007OSTK19-012026-03-23
20809160517199HalyardDUAC16-01_0010DUAC16-012026-03-23
20809160517205HalyardVAML058_0017VAML0582026-03-23
20809160517212HalyardSAMT100-12_0007SAMT100-122026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10198956486874CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956487659CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956487857CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956488182CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956488878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956489578CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10809160521748MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRO2026-05-22
10809160521762HalyardAVID MEDICAL, INC.LRO2026-05-22
10809160521779HalyardAVID MEDICAL, INC.LRO2026-05-22
10809160521793HalyardAVID MEDICAL, INC.LRO2026-05-22
10809160521809HalyardAVID MEDICAL, INC.LRO2026-05-22
10885632521751SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-05-22
50198956219043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956300116CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956306866CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956327939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956334760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956359893CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956379167CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956379211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956382150CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391329CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956391541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392616CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956392890CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956394542CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956399073CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956414585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956414806CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24
50198956415230CARDINAL HEALTHCardinal Health 200, LLCLRO2026-03-24