FDA.reportPublic FDA data

Halyard

Primary DI
10809160538364
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
GTMO010-05
Published
2026-09-21
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160538361PackageGS12In Commercial Distribution
10809160538364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053836120809160538361
1080916053836410809160538364

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this 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
10809160540879MEDICAL ACTION INDUSTRIES79143C2026-10-20
10809160540626HalyardLLOF2700-022026-10-14
10809160540473Medical Action IndustriesLH_851772026-10-12
10809160540480HalyardSHAN454-052026-10-12
10809160540107Medical Action IndustriesLMHA01-012026-10-08
10809160183472Medical Action Industries773452018-03-22
10809160536803HalyardHVMC003-042026-09-18
10809160539965Medical Action Industries845252026-10-06
10809160539125HalyardLLOF021-012026-09-30
10809160539019Medical Action Industries83989B2026-09-25
10809160539026HalyardDNAZ037-032026-09-25
10809160535523HalyardLLOF3100-022026-09-24
10809160538913HalyardMHSH2002-012026-09-24
10809160538937HalyardAXOG2000-122026-09-24
10809160538968HalyardDNAZ034-032026-09-24
10809160538999HalyardLLOF006-012026-09-24
10809160536889HalyardMEPK70E-012026-09-22
10809160538579HalyardVMED013-062026-09-22
10809160538609HalyardLH_267001_B12026-09-22
10809160538326HalyardSLNC22-022026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956588738CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956592407CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956602380CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956605534CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956606654CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956612099CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956598478CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956601345CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956604285CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956608726CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956545267CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956569003CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956598751CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956599130CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956348776CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956573291CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956580121CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956596771CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956558328CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956591769CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956596368CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956598423CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956450684CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956519022CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956557574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956568136CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956572041CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956580848CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956586000CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956589186CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25