FDA.reportPublic FDA data

Halyard

Primary DI
20809160495022
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
DADC011-02_0005
Catalog number
DADC011-02
Published
2025-09-23
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
20809160495022PackageGS125In Commercial Distribution
10809160495025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916049502220809160495022
1080916049502510809160495025

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.

Sterilization Methods#

Method table
Method

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160522660HalyardDGAD64-01_0007DGAD64-012026-06-05
10809160522677HalyardVMCL027-13_0002VMCL027-132026-06-05
10809160522684HalyardLLTV10-01_0003LLTV10-012026-06-05
10809160522691HalyardHVSP211-03_0003HVSP211-032026-06-05
10809160522707HalyardBJAC006-29_0008BJAC006-292026-06-05
10809160522714HalyardAXOGSUB3-11_0002AXOGSUB3-112026-06-05
10809160522721HalyardBMHU005-05_0001BMHU005-052026-06-05
10809160522738HalyardGVVA002-08_0008GVVA002-082026-06-05
10809160522745HalyardHOTH40D_0008HOTH40D2026-06-05
10809160522752HalyardDUTT20_0005DUTT202026-06-05
10809160522769HalyardFBCH126-02_0005FBCH126-022026-06-05
10809160522776HalyardBMHU003-04_0004BMHU003-042026-06-05
10809160522783HalyardACTK56-03_0007ACTK56-032026-06-05
10809160469972HalyardAMTS70-012025-06-12
10809160479148HalyardLMDP36-01LMDP36-012025-07-09
10809160484098HalyardUIEB48-01UIEB48-012025-07-09
10809160522554HalyardAVMD011-03_0006AVMD011-032026-06-04
10809160522561HalyardJACK410-11_0005JACK410-112026-06-04
10809160522578HalyardDGNE75-02_0011DGNE75-022026-06-04
10809160522585HalyardLCNW004-01_0001LCNW004-012026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956078789CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956266063CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956305861CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956349261CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956354241CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956365902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956369900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956377240CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956383081CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956385993CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956386266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956391598CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956414426CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956439313CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956445079CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956446694CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956453784CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956460409CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956466302CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956470415CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956470422CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956473126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956473232CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956476622CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477704CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477766CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477889CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05