FDA.reportPublic FDA data

Halyard

Primary DI
10809160532782
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
KAFB008-10_0016
Catalog number
KAFB008-10
Published
2026-09-04
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
20809160532789PackageGS15In Commercial Distribution
10809160532782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053278920809160532789
1080916053278210809160532782

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.

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160532676HalyardMSBS14-05_0006MSBS14-052026-09-04
10809160532683HalyardMSTK53-06_0002MSTK53-062026-09-04
10809160532690HalyardMSCS51-06_0005MSCS51-062026-09-04
10809160532706HalyardSFSBPAR65-02_0003SFSBPAR65-022026-09-04
10809160532713HalyardBPAR65-02_0002BPAR65-022026-09-04
10809160532737HalyardFBCH103-07_0015FBCH103-072026-09-04
10809160532744HalyardMSTK53-07_0001MSTK53-072026-09-04
10809160532768HalyardBKAP27-03_0006BKAP27-032026-09-04
10809160532775HalyardEURO053-02_0003EURO053-022026-09-04
10809160532799HalyardWRNM019-16_0003WRNM019-162026-09-04
10809160532805HalyardNAMC436-13_0007NAMC436-132026-09-04
10809160532812HalyardNAMC433-07_0008NAMC433-072026-09-04
10809160532829HalyardWRNM025-12_0005WRNM025-122026-09-04
10809160532836HalyardEAMC1000-05AUX2_0002EAMC1000-05AUX22026-09-04
10809160532843HalyardWRNM007-18_0003WRNM007-182026-09-04
10809160532850HalyardNAMC474-06_0004NAMC474-062026-09-04
10809160532867HalyardBAAK106-15_0002BAAK106-152026-09-04
10809160532874HalyardKAFB009-16_0004KAFB009-162026-09-04
10809160532881HalyardFBCH130-04_0005FBCH130-042026-09-04
10809160532898HalyardEURO005-10_0004EURO005-102026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532966HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532973HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532980HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532997HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533000HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533017HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533024HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533031HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533048HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533055HalyardAVID MEDICAL, INC.LRO2026-09-05
10198956333420CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956395947CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956462977CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956486058CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956530744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956531611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956535985CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541177CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956542532CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546509CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956547285CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956548022CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956551763CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552364CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552401CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956553385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554429CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04