FDA.reportPublic FDA data

Halyard

Primary DI
10809160537183
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
WFUM9497-03
Published
2026-09-18
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
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160537180PackageGS112In Commercial Distribution
10809160537183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053718020809160537180
1080916053718310809160537183

GMDN Terms#

Term, Definition table
TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. 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

Regulatory Flags#

DUNS number
092364462
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
10809160536506HalyardLLOG1000-182026-09-18
10809160536544HalyardSHSD015-042026-09-18
10809160536612HalyardWBAM068-042026-09-18
10809160536629HalyardSLAK19-042026-09-18
10809160536667HalyardSWDS001-022026-09-18
10809160536674HalyardLOUS019-162026-09-18
10809160536681HalyardLCNW001-122026-09-18
10809160536728HalyardSHAN453-052026-09-18
10809160536735HalyardLCNW002-032026-09-18
10809160536742HalyardFLDR004-022026-09-18
10809160536759HalyardLIFE0070-082026-09-18
10809160536766HalyardLOUS018-022026-09-18
10809160536773HalyardRDLD033-062026-09-18
10809160536797HalyardMSMT46-062026-09-18
10809160536803HalyardHVMC003-042026-09-18
10809160536810HalyardKRIV26-032026-09-18
10809160536827HalyardMETC002-042026-09-18
10809160536834HalyardLAKC032-022026-09-18
10809160536841HalyardRDLD039-102026-09-18
10809160536858HalyardONEL038-022026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160536902HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536940HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536971HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536988HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536995HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537060HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537145HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537152HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537169HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537176HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537190HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537206HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537213HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537220HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537237HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537244HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537251HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537268HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537275HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537282HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537329HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537404HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10198956037908CARDINAL HEALTHCardinal Health 200, LLCOVN2026-09-04
14026704724106DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704725066DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704725073DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704724120DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
14026704724182DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
10809160528006MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-07-28
10809160523155MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-06-09