FDA.reportPublic FDA data

Halyard

Primary DI
20809160369781
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SAMM024-05_0007
Catalog number
SAMM024-05
Published
2022-04-26
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

Contact Domains#

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
20809160369781PackageGS14In Commercial Distribution
10809160369784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916036978120809160369781
1080916036978410809160369784

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521830HalyardAVID MEDICAL, INC.LRO2026-05-26
10198956328457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956348189CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956380127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956383647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956387287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956388406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956413757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956416802CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956426146CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956427242CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956430174CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956437265CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956441910CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444775CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956445680CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956453753CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956455528CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956456624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457096CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457713CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956460638CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956461741CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956462014CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956463516CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956464360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465831CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465855CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25