FDA.reportPublic FDA data

HALYARD

Primary DI
10809160543726
Brand
HALYARD
Company
MEDICAL ACTION INDUSTRIES INC.
Model
DNGL88
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160543723PackageGS13In Commercial Distribution
10809160543726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054372320809160543723
1080916054372610809160543726

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
10809160543733HALYARDDNKN062026-11-04
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
10198956627840CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-03
B098AMS4331D0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-30
10198956503519CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-29
10198956611627CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-29
10198956549524CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-23
10198956575172CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956589940CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956590847CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956599055CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602700CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602717CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956603547CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956605633CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956606265CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956608238CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956609624CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956609686CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602861CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-15
B098AMS198710Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-14
10198956586574CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956596764CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956597570CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956506121CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956599222CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956604896CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956610231CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
B098AMS16041C0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-02
10198956594845CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956596528CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956567597CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29