FDA.reportPublic FDA data

Halyard

Primary DI
10809160540442
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
MAMC235-17_0001
Catalog number
MAMC235-17
Published
2026-10-09
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
20809160540449PackageGS13In Commercial Distribution
10809160540442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054044920809160540449
1080916054044210809160540442

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, medicatedA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform an ENT surgical procedure. 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
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160540497HALYARDBPKN15-02BPKN15-022026-10-12
10809160540510HALYARDBPCL47-02BPCL47-022026-10-12
10809160540527HALYARDBPEX22-02BPEX22-022026-10-12
10809160540534HALYARDBPLA73-02BPLA73-022026-10-12
10809160540541HALYARDBPSA20-02BPSA20-022026-10-12
10809160540558HALYARDGBPM39-02GBPM39-022026-10-12
10809160540428HalyardEURO017-10_0002EURO017-102026-10-09
10809160540435HalyardEAMC103-08_0005EAMC103-082026-10-09
10809160540459HalyardMAMC220-12_0002MAMC220-122026-10-09
10809160540466HalyardDNKN06_0012DNKN062026-10-09
10809160540091HalyardSGEP43-03_0005SGEP43-032026-10-08
10809160540114HalyardDNSP11_0008DNSP112026-10-08
10809160540121HalyardDNVP97_0006DNVP972026-10-08
10809160540138HalyardDNPP09_0011DNPP092026-10-08
10809160540145HalyardDNAG08_0011DNAG082026-10-08
10809160540152HalyardDNUR81_0005DNUR812026-10-08
10809160540169HalyardDULP98-03_0001DULP98-032026-10-08
10809160540176HalyardVAST024-08_0013VAST024-082026-10-08
10809160540183HalyardDUPR37-03_0001DUPR37-032026-10-08
10809160540190HalyardDUCR36-03_0001DUCR36-032026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956331259CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956352230CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956399051CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956507425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956508057CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956519701CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956523142CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956537491CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956540620CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956542716CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956546110CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956551015CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956553699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956554689CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956555709CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956558335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956566699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568143CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568181CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568662CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956569942CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956570931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956572195CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956572706CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956580435CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956581128CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956582910CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956584860CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956586772CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956587250CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12