FDA.report

Halyard

Primary DI
20809160333133
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VAST004-07_0004
Catalog number
VAST004-07
Published
2020-12-11
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
20809160333133PackageGS12In Commercial Distribution
10809160333136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916033313320809160333133
1080916033313610809160333136

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
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10809160521830HalyardAVID MEDICAL, INC.LRO2026-05-26
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10198956457959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
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10198956463516CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956464360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
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10198956465855CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25