FDA.reportPublic FDA data

Halyard

Primary DI
10809160522448
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
DGLP47-02_0008
Catalog number
DGLP47-02
Published
2026-06-02
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
20809160522445PackageGS14In Commercial Distribution
10809160522448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052244520809160522445
1080916052244810809160522448

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
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
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
10809160522165HalyardEURO011-09_0003EURO011-092026-06-01
10809160522172HalyardWILF024-22_0001WILF024-222026-06-01
10809160522189HalyardWILF011-24_0001WILF011-242026-06-01
10809160522196HalyardSGRB86-04_0006SGRB86-042026-06-01
10809160522202HalyardWILF004-22_0001WILF004-222026-06-01
10809160522219HalyardWILF027-21_0001WILF027-212026-06-01
10809160522233HalyardAVMD023-03_0001AVMD023-032026-06-01
10809160522240HalyardWILF002-23_0001WILF002-232026-06-01
10809160522257HalyardEURO018-08_0006EURO018-082026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522332HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522349HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522356HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522363HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522370HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522394HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522400HalyardAVID MEDICAL, INC.LRO2026-06-02
10198956004887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956245754CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956248908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956312043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314634CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314894CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956321717CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956356184CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956370760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956376793CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956377363CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384750CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384873CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385160CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956391970CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956406193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956439399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956440685CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444850CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956445833CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956451377CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01