FDA.reportPublic FDA data

HALYARD

Primary DI
10809160543733
Brand
HALYARD
Company
MEDICAL ACTION INDUSTRIES INC.
Model
DNKN06
Published
2026-11-04
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160543730PackageGS14In Commercial Distribution
10809160543733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054373020809160543730
1080916054373310809160543733

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
10809160534991HalyardSHSD010-022026-09-15
10809160543566HalyardSELF1422026-11-03
10809160543641HalyardSHSD016-012026-11-03
10809160543658HalyardDUES172026-11-03
10809160543665HalyardSELF141-012026-11-03
10809160543672HALYARDWBAM032-122026-11-03
10809160543689HalyardDUTT202026-11-04
10809160543719HALYARDDNCS202026-11-04
10809160543726HALYARDDNGL882026-11-04
10809160543740HALYARDDNLD362026-11-04
10809160543757HALYARDDNME372026-11-04
10809160543764HALYARDDNMP252026-11-04
10809160543771HALYARDDNTA212026-11-04
10809160543788HALYARDDNTJ022026-11-04
10809160543795HALYARDDNTK092026-11-04
10809160542255MEDICAL ACTION INDUSTRIES77719D2026-10-29
10809160542286MEDICAL ACTION INDUSTRIESLH_851922026-10-29
10809160542019HALYARDDUGR84-012026-10-28
10809160542026HALYARDDUYV76-032026-10-28
10809160542033HALYARDDAHA30-022026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160543757HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543788HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10809160543795HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-11-04
10198956569805CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956603806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956603936CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956607811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956612433CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956612556CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956615465CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956620728CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956620919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621183CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621350CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956621640CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956623156CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956623330CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624146CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624276CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956624368CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625358CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625747CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956625846CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
10198956626010CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-03
B098AMS18754A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-11-02
B098AMS18911A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-11-02
10809160542309HalyardAVID MEDICAL, INC.OJH2026-10-31
B098AMS14091A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-30
B098AMS200760Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-30
10198956359888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29