FDA.reportPublic FDA data

MEDICAL ACTION INDUSTRIES

Primary DI
10809160521748
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
84957
Published
2026-05-22
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
20809160521745PackageGS120In Commercial Distribution
10809160521748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052174520809160521745
1080916052174810809160521748

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
10809160527665MEDICAL ACTION INDUSTRIES849602026-07-21
10809160527054Medical Action Industries78216C2026-07-14
10809160527078MEDICAL ACTION INDUSTRIES848842026-07-14
10809160527030MEDICAL ACTION INDUSTRIES848882026-07-13
10809160526866MEDICAL ACTION INDUSTRIES850202026-07-08
10809160526873MEDICAL ACTION INDUSTRIES849172026-07-08
10809160526750MEDICAL ACTION INDUSTRIES851662026-07-06
10809160526774HALYARD849182026-07-06
10809160526781HALYARD849162026-07-06
10809160231869Medical Action IndustriesLH_71171B2019-03-20
10809160476505Medical Action Industries843102025-07-09
10809160523155MEDICAL ACTION INDUSTRIES850142026-06-09
10809160226100Splash Medical Devices715622019-02-05
10809160522790Medical Action Industries851072026-06-05
10809160522806Medical Action Industries851642026-06-05
10809160522479Medical Action Industries848692026-06-03
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17798A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS179150Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190180Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190730Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS194550Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS195260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS13932C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS16019B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS17843A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS18256A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS187260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS5861D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
10809160527825HalyardAVID MEDICAL, INC.LRO2026-07-24
10809160527788HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527801HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527818HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS174900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21