FDA.reportPublic FDA data

Medical Action Industries

Primary DI
10809160188736
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
78140
Published
2018-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160188733PackageGS120Not in Commercial Distribution
10809160188736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916018873320809160188733
1080916018873610809160188736

GMDN Terms#

Term, Definition table
TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. 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
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160528297Medical Action Industries849632026-07-31
10809160528068MEDICAL ACTION INDUSTRIES77345B2026-07-29
10809160526774Medical Action Industries849182026-07-06
10809160526781Medical Action Industries849162026-07-06
10809160497081Medical Action Industries844922025-10-10
10809160528006MEDICAL ACTION INDUSTRIES84492B2026-07-28
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704724120DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
14026704724182DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
10809160528006MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-07-28
10809160523155MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-06-09
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10198956241848CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
10198956284562CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956284678CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25