FDA.reportPublic FDA data

Halyard

Primary DI
10809160541760
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
AV010908-15
Published
2026-10-26
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

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
20809160541767PackageGS12In Commercial Distribution
10809160541760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054176720809160541767
1080916054176010809160541760

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

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
10809160541531HalyardGTMO0072026-10-26
10809160541722HalyardDADC008-032026-10-26
10809160541739HALYARDLLOG020-042026-10-26
10809160541746HalyardONEL1165-042026-10-26
10809160541753HalyardONEL1170-052026-10-26
10809160541470HalyardLCOD004-012026-10-23
10809160541487HalyardDADC009-032026-10-23
10809160541494HalyardONEL1180-052026-10-23
10809160541500HALYARDMETC002-012026-10-23
10809160541517HALYARDWBAM068-032026-10-23
10809160541524HALYARDVMED013-032026-10-23
10809160538913HalyardMHSH2002-012026-09-24
10809160541029Medical Action IndustriesDNAG082026-10-21
10809160541036Medical Action IndustriesDNPP092026-10-21
10809160541043Medical Action IndustriesDNSP112026-10-21
10809160541050Medical Action IndustriesDNUR812026-10-21
10809160541067Medical Action IndustriesDNVP972026-10-21
10809160540879MEDICAL ACTION INDUSTRIES79143C2026-10-20
10809160540626HalyardLLOF2700-022026-10-14
10809160540473Medical Action IndustriesLH_851772026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956515376CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956577282CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956578869CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956590359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956592902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956596214CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956603752CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956613256CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616646CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616745CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616776CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956617612CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956621961CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956626287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10809160541548HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541586HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541609HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541623HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541630HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541647HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541654HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541661HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541678HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541685HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541692HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541708HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541715HalyardAVID MEDICAL, INC.LRO2026-10-26
B098AMS10429D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-26
B098AMS14372A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-26