FDA.reportPublic FDA data

Halyard

Primary DI
10809160537374
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
USMA005-03
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10809160537374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053737410809160537374

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, medicatedA collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. 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
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
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
10809160537633HalyardAVID MEDICAL, INC.OJG2026-09-19
10809160537725HalyardAVID MEDICAL, INC.OJG2026-09-19
10809160536445HalyardAVID MEDICAL, INC.OJG2026-09-18
10809160537046HalyardAVID MEDICAL, INC.OJG2026-09-18
10809160537305HalyardAVID MEDICAL, INC.OJG2026-09-18
10809160537336HalyardAVID MEDICAL, INC.OJG2026-09-18
10198956475113CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956486362CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956491304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956518667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956554948CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956555389CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559691CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559974CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956560895CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562509CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562707CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563186CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563575CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569126CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569751CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570092CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570139CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570313CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571686CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571716CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571761CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956572386CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04