FDA.reportPublic FDA data

Halyard

Primary DI
10809160528488
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
BMHT400-03_0013
Catalog number
BMHT400-03
Published
2026-08-03
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10809160528488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916052848810809160528488

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device.

Regulatory Flags#

DUNS number
015623119
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160528365HalyardPSJH0015-02_0014PSJH0015-022026-08-03
10809160528372HalyardSFSAKOR36-02_0001SFSAKOR36-022026-08-03
10809160528389HalyardAKOR36-03_0002AKOR36-032026-08-03
10809160528396HalyardAKCR19-03_0003AKCR19-032026-08-03
10809160528402HalyardBMHT500-03_0005BMHT500-032026-08-03
10809160528419HalyardBMHU006-07_0007BMHU006-072026-08-03
10809160528426HalyardSELF137-05_0005SELF137-052026-08-03
10809160528433HalyardLANC039-31_0002LANC039-312026-08-03
10809160528440HalyardBMHT202-05_0004BMHT202-052026-08-03
10809160528457HalyardBMHT401-04_0006BMHT401-042026-08-03
10809160528464HalyardESCC82-02_0010ESCC82-022026-08-03
10809160528471HalyardLANC015-35_0011LANC015-352026-08-03
10809160528495HalyardBAMW001-03_0002BAMW001-032026-08-03
10809160528501HalyardQPTH29-02_0007QPTH29-022026-08-03
10809160528518HalyardSFSBMHU006-07_0001SFSBMHU006-072026-08-03
10809160528525HalyardHVBM219-04_0005HVBM219-042026-08-03
10809160528532HalyardSFSBAMW001-03_0001SFSBAMW001-032026-08-03
10809160528549HalyardMEEN42-03_0007MEEN42-032026-08-03
10809160528556HalyardDAMH300-03_0005DAMH300-032026-08-03
10809160528563HalyardDAMH309-05_0003DAMH309-052026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528518HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528525HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528532HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528549HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528556HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528570HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528594HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528617HalyardAVID MEDICAL, INC.LRO2026-08-03
10885632528620SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-03
B098AMS16817B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS17579A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178970Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS191170Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
10809160528341HALYARDAVID MEDICAL, INC.LRO2026-08-01
10198956352315CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956364998CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956395503CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956453180CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956485358CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956494909CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31