FDA.reportPublic FDA data

Medical Action Industries

Primary DI
20809160486402
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
PAEY10H
Published
2025-07-23
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160486402PackageGS18In Commercial Distribution
10809160486405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916048640220809160486402
1080916048640510809160486405

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any 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
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
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15
10809160521427MEDICAL ACTION INDUSTRIES848572026-05-15
10809160521434MEDICAL ACTION INDUSTRIES81183F2026-05-15
10809160521441Medical Action Industries81183E2026-05-15
10809160168493Medical Action Industries76828B2017-10-27
10809160520925MEDICAL ACTION INDUSTRIES847172026-05-11
10809160345108Medical Action Industries80391B2021-02-05
10809160429389Medical Action Industries840862024-07-10
10809160520635Medical Action Industries83349B2026-05-07
10809160520468Medical Action Industries771202026-05-05
10809160016770Medical Action Industries718912016-08-20
10809160394052Medical Action Industries833482023-02-09
10809160435038Medical Action Industries838262024-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10193489217391Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
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10193489417180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489421590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489422702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489424133Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
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10193489449471Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489453256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489453485Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489455670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489457209Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08