FDA.reportPublic FDA data

Medical Action Industries

Primary DI
20809160404550
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
83515
Published
2023-07-10
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
OIPRadiology-diagnostic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160404550PackageGS120In Commercial Distribution
10809160404553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916040455020809160404550
1080916040455310809160404553

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access kit, single-useA collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. 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

Sterilization Methods#

Method table
Method

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
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
20809160517113MEDICAL ACTION INDUSTRIES843992026-03-23
20809160516574Medical Action Industries82274B2026-03-19
20809160016463Medical Action Industries716912016-08-20
20809160515195Clear Sequence836992026-03-06
20809160515218MEDICAL ACTION INDUSTRIES848602026-03-06
20809160515157MEDICAL ACTION INDUSTRIES847242026-03-05
20809160514938Medical Action Industries81329E2026-03-04
20809160514990Medical Action Industries76567F2026-03-04
20809160515003Medical Action Industries78304B2026-03-04
20809160515027Medical Action Industries77156B2026-03-04
20809160514754MEDICAL ACTION INDUSTRIES82438B2026-03-03
20809160514761MEDICAL ACTION INDUSTRIES82436B2026-03-03
20809160514136Medical Action Industries837402026-02-26
20809160513856Medical Action Industries822742026-02-25
20809160513924MEDICAL ACTION INDUSTRIES848192026-02-25
20809160513337MEDICAL ACTION INDUSTRIES82274C2026-02-20
20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191072242037ACSAMERICAN CONTRACT SYSTEMS, INC.OIP2026-03-24
50198956418415CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-24
50198956141207CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956338461CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956415209CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956329537CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956341997CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956381238CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956425802CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956318166CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956388183CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956395341CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956408430CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-06
50198956351392CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-03
50198956331431CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956372601CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956373868CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956377279CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956383973CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956386691CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956335613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956368710CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956297843CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-20
50198956322613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956330847CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956167566CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956324075CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956325935CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956345001CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956334920CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-29