FDA.reportPublic FDA data

Halyard

Primary DI
20809160471590
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
IAUR12-01
Catalog number
IAUR12-01
Published
2025-07-02
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160471590PackageGS14In Commercial Distribution
10809160471593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916047159020809160471590
1080916047159310809160471593

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods#

Method table
Method

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
00677964153617Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153624Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153631Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153648Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153655Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153662Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153679Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153686Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153693Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153709Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153716Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153723Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153730Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153747Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153754Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153761Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153778Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153785Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
10198956057005CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956358003CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956376953CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956441071CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956444508CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956454460CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956463042CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956463264CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956465183CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956469297CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956480889CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956484313CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25