FDA.reportPublic FDA data

Halyard

Primary DI
10809160540824
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
USAR034-20_0013
Catalog number
USAR034-20
Published
2026-10-19
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
20809160540821PackageGS13In Commercial Distribution
10809160540824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054082120809160540821
1080916054082410809160540824

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological 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
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
10809160540787HalyardBPVP85-01_0002BPVP85-012026-10-19
10809160540794HalyardTNCA09_0007TNCA092026-10-19
10809160540800HalyardJCLC12F_0009JCLC12F2026-10-19
10809160540817HalyardMWOS97-02MWOS97-022026-10-19
10809160540831HalyardEURO055-01_0007EURO055-012026-10-19
10809160540664HalyardDUDV85-02_0001DUDV85-022026-10-16
10809160540671HalyardDAGV13-03_0001DAGV13-032026-10-16
10809160540688HalyardDGAG83-05_0001DGAG83-052026-10-16
10809160540695HalyardDAGL72-02_0001DAGL72-022026-10-16
10809160540701HALYARDBPHD16-02BPHD16-022026-10-16
10809160540718HALYARDBPKB46-02BPKB46-022026-10-16
10809160540725HALYARDBPSF60-02BPSF60-022026-10-16
10809160540732HalyardSPSA58-02SPSA58-022026-10-16
10809160540756HALYARDBPCY61-02BPCY61-022026-10-16
10809160540763HALYARDBPTH37-02BPTH37-022026-10-16
10809160540657HalyardSELF154_0011SELF1542026-10-15
10809160540565HalyardMSBM032-06_0002MSBM032-062026-10-13
10809160540572HalyardSOLC12A-01_0003SOLC12A-012026-10-13
10809160540589HalyardEAMC102-10_0003EAMC102-102026-10-13
10809160540596HalyardDUAD22-01_0008DUAD22-012026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426262069Medline-MicrotekMicrotek Medical LLCLRO2026-10-19
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10198956499980CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956519527CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956542457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956544147CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956567627CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956568495CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956568501CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956569300CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956572607CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956581173CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956581234CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583016CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583979CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583993CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956584884CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956585096CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956586512CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956587137CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956591097CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956591738CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956594197CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956595569CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956596122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956602656CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19