FDA.reportPublic FDA data

Halyard

Primary DI
10809160522509
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
AXOGSUB3-11_0016
Catalog number
AXOGSUB3-11
Published
2026-06-03
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
20809160522506PackageGS16In Commercial Distribution
10809160522509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052250620809160522506
1080916052250910809160522509

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10809160522455HalyardAVMD023-03_0004AVMD023-032026-06-03
10809160522462HalyardDHOR82-01_0005DHOR82-012026-06-03
10809160522486HalyardLIFE0234-03_0001LIFE0234-032026-06-03
10809160522493HalyardAVMD011-03_0004AVMD011-032026-06-03
10809160522523HalyardMCTJ74-01_0011MCTJ74-012026-06-03
10809160522530HalyardPSJH0015-01_0012PSJH0015-012026-06-03
10809160522332HalyardEURO055_0005EURO0552026-06-02
10809160522349HalyardUSAR052-17_0004USAR052-172026-06-02
10809160522356HalyardWILF002-23_0003WILF002-232026-06-02
10809160522363HalyardSGRB86-04_0009SGRB86-042026-06-02
10809160522370HalyardWINN109-05_0015WINN109-052026-06-02
10809160522387HalyardONEL028-03_0007ONEL028-032026-06-02
10809160522394HalyardNAMC414-09_0004NAMC414-092026-06-02
10809160522400HalyardKAFB005-21_0005KAFB005-212026-06-02
10809160522417HalyardSGSP11-03_0003SGSP11-032026-06-02
10809160522424HalyardMEHY02O_0009MEHY02O2026-06-02
10809160522431HalyardBMHT033-02_0010BMHT033-022026-06-02
10809160522448HalyardDGLP47-02_0008DGLP47-022026-06-02
10809160522165HalyardEURO011-09_0003EURO011-092026-06-01
10809160522172HalyardWILF024-22_0001WILF024-222026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956346369CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956348950CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956363922CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956386099CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956390928CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956391437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956399945CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956427693CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956434004CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956439436CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956441934CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956444119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956463035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956470071CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956471306CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956474703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477049CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477759CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956478077CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956480841CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956482012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956486683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489318CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489844CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956490062CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956490383CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956490550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956492417CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956492844CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03