FDA.reportPublic FDA data

Halyard

Primary DI
10809160538449
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
REDI001-01
Published
2026-09-21
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
20809160538446PackageGS140In Commercial Distribution
10809160538449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053844620809160538446
1080916053844910809160538449

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.

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
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160535523HalyardLLOF3100-022026-09-24
10809160538913HalyardMHSH2002-012026-09-24
10809160538937HalyardAXOG2000-122026-09-24
10809160538968HalyardDNAZ034-032026-09-24
10809160538999HalyardLLOF006-012026-09-24
10809160536889HalyardMEPK70E-012026-09-22
10809160538579HalyardVMED013-062026-09-22
10809160538609HalyardLH_267001_B12026-09-22
10809160538326HalyardSLNC22-022026-09-21
10809160538333HalyardBHPK801-012026-09-21
10809160538340HalyardASLH9728-012026-09-21
10809160538357HalyardBUFF100-032026-09-21
10809160538364HalyardGTMO010-052026-09-21
10809160538371HalyardMISS803-032026-09-21
10809160538388HalyardDONS108-022026-09-21
10809160538395HalyardSILV800-022026-09-21
10809160538401HalyardKOOT800-022026-09-21
10809160538418HalyardSAMR9825-012026-09-21
10809160538425HalyardGTMO009-032026-09-21
10809160538432HalyardWFUM9498-032026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160535523HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-09-24
10885632538902SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-09-24
10198956273979CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956336667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956373839CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956388338CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956426283CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956481978CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956495470CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956503700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956521193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956530669CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956532052CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956533905CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956547513CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956549555CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956550476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956554108CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956555877CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557284CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956558427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956559936CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956561809CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956562059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956564589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956565074CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956566163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956568952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956569683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22