FDA.reportPublic FDA data

Halyard

Primary DI
10809160541807
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
DUNE88-01
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160541804PackageGS12In Commercial Distribution
10809160541807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054180420809160541804
1080916054180710809160541807

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160542019HALYARDDUGR84-012026-10-28
10809160542026HALYARDDUYV76-032026-10-28
10809160542033HALYARDDAHA30-022026-10-28
10809160542040HalyardDRRD93-012026-10-28
10809160542057HALYARDDUAV18-022026-10-28
10809160542064HalyardDUMD33-012026-10-28
10809160542071HalyardDUTC93-012026-10-28
10809160542088HalyardDAAU122026-10-28
10809160542095HALYARDDUMF13-022026-10-28
10809160542101HalyardDRNE38-022026-10-28
10809160542118HalyardLCOD005-012026-10-28
10809160542125HalyardSWDS0072026-10-28
10809160542132HalyardSWDS0062026-10-28
10809160542149HalyardDRPM81-012026-10-28
10809160542156HalyardWH0022-032026-10-28
10809160542170HalyardGUNH004-052026-10-28
10809160542187HalyardHWEX25-012026-10-28
10809160542194HalyardSCAV001-032026-10-28
10809160541784HALYARDDUTY24-022026-10-27
10809160541791HALYARDLLOF5109-052026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542101HalyardMEDICAL ACTION INDUSTRIES INC.OJG2026-10-28
10809160541906HalyardMEDICAL ACTION INDUSTRIES INC.OJG2026-10-27
10198956565784CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-26
10198956566705CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-26
10198956598485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-26
10198956620933CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-26
10198956332553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956504899CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956548923CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956562936CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956570702CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956595934CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956597020CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956600072CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956602588CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956604445CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956609204CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956611399CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956612594CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956619326CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
B098AMS12195E0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-10-23
10198956038127CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956268111CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956537439CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956562660CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956565586CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956592209CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956598027CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956599321CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956604087CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19