FDA.reportPublic FDA data

HALYARD

Primary DI
10809160543771
Brand
HALYARD
Company
MEDICAL ACTION INDUSTRIES INC.
Model
DNTA21
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
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160543778PackageGS18In Commercial Distribution
10809160543771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054377820809160543778
1080916054377110809160543771

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
10809160543733HALYARDDNKN062026-11-04
10809160543740HALYARDDNLD362026-11-04
10809160543757HALYARDDNME372026-11-04
10809160543764HALYARDDNMP252026-11-04
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
10198956521032CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956537484CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956554313CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956583870CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956596344CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956619944CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956577107CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-26
10198956611719CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-26
10198956585058CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956590830CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956595798CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956597082CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956607477CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
B098AMS199620Aligned Medical SolutionsAligned Medical SolutionsOGR2026-10-23
10198956548862CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956551961CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956561885CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956562943CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956567610CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956584006CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956598454CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956601338CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956602397CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956602632CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956604117CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956604865CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956605435CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956609853CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956611146CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956592483CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-15