FDA.reportPublic FDA data

Halyard

Primary DI
20809160460921
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
FTDC01-01_0011
Catalog number
FTDC01-01
Published
2025-03-20
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

Contact Domains#

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
20809160460921PackageGS13In Commercial Distribution
10809160460924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916046092120809160460921
1080916046092410809160460924

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

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
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08
10809160522844HalyardSFSJACK435-09_0001SFSJACK435-092026-06-08
10809160522851HalyardBMHU003-05_0001BMHU003-052026-06-08
10809160522868HalyardSFSMSBM022-06_0001SFSMSBM022-062026-06-08
10809160522875HalyardMSBM030-06_0007MSBM030-062026-06-08
10809160522882HalyardMSBM022-06_0006MSBM022-062026-06-08
10809160522899HalyardJACK435-09_0005JACK435-092026-06-08
10809160522905HalyardSFSMSBM030-06_0002SFSMSBM030-062026-06-08
10809160522912HalyardJACK455-05_0001JACK455-052026-06-08
10809160522929HalyardSFSJCLC12-01_0001SFSJCLC12-012026-06-08
10809160522936HalyardSHAN453-04_0015SHAN453-042026-06-08
10809160522943HalyardBMHT030-05_0003BMHT030-052026-06-08
10809160522950HalyardMAMC229-22_0001MAMC229-222026-06-08
10809160522967HalyardACTK56-03_0008ACTK56-032026-06-08
10809160522974HalyardDGAL24-03_0007DGAL24-032026-06-08
10809160522981HalyardAVMD016-02_0005AVMD016-022026-06-08
10809160522998HalyardMEHY02O_0011MEHY02O2026-06-08
10809160523001HalyardMCBP83-02_0005MCBP83-022026-06-08
10809160523018HalyardMAMC213-09_0004MAMC213-092026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106911266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
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10198956429666CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956432048CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956433144CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956443518CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956466012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956467484CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469204CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956473423CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477292CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477339CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483378CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483903CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956484368CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956487406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956492660CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956493667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956495371CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496170CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496507CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496705CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496781CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496835CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956497122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956498884CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08