FDA.reportPublic FDA data

Halyard

Primary DI
10809160532089
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SFSKAFB008-10_0001
Catalog number
SFSKAFB008-10
Published
2026-08-27
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
10809160532089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053208910809160532089

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160531853HalyardDGAL24-03_0010DGAL24-032026-08-27
10809160531860HalyardDGBB41-02_0006DGBB41-022026-08-27
10809160531877HalyardDGIV63_0008DGIV632026-08-27
10809160531884HalyardDUAD22-01_0004DUAD22-012026-08-27
10809160531891HalyardDUCC54_0009DUCC542026-08-27
10809160531907HalyardDUEC27-01_0004DUEC27-012026-08-27
10809160531914HalyardSJGH109-07_0007SJGH109-072026-08-27
10809160531921HalyardSFSEURO028-07_0001SFSEURO028-072026-08-27
10809160531938HalyardSHND415-02_0001SHND415-022026-08-27
10809160531945HalyardSOTJ41-01_0007SOTJ41-012026-08-27
10809160531952HalyardNAMC425-08_0013NAMC425-082026-08-27
10809160531969HalyardWAFB224-03_0007WAFB224-032026-08-27
10809160531976HalyardSFSBAAK106-15_0001SFSBAAK106-152026-08-27
10809160531983HalyardSFSEABF007-15_0001SFSEABF007-152026-08-27
10809160531990HalyardSFSBUAH026-24_0001SFSBUAH026-242026-08-27
10809160532003HalyardSFSEAMC114-07_0001SFSEAMC114-072026-08-27
10809160532010HalyardWRNM004-18_0004WRNM004-182026-08-27
10809160532027HalyardEURO002-11_0005EURO002-112026-08-27
10809160532034HalyardSFSEURO010-10_0001SFSEURO010-102026-08-27
10809160532041HalyardEURO013-11_0005EURO013-112026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531860HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531877HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531914HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531921HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531945HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531952HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531976HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531983HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531990HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532010HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532034HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532041HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532058HalyardAVID MEDICAL, INC.LRO2026-08-27
10198956437746CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956504462CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956509078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956511163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956523814CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956524446CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956531703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534896CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534971CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535107CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535473CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956537576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956544499CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956547636CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956548404CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956549937CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956551985CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26