FDA.reportPublic FDA data

Medline

Primary DI
10080196115945
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYK1073585E
Catalog number
DYK1073585E
Device description
KIT,POST OP EYE,TRIDENT
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
40080196115946PackageGS125In Commercial Distribution
10080196115945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019611594640080196115946
1008019611594510080196115945

GMDN Terms#

Term, Definition table
TermDefinition
Moisture chamber spectaclesA personal protective device used to shield the eyes of an individual by forming a semi-closed chamber around each eye to retain the natural eye moisture and help keep the eyes lubricated. It consists of a spectacle frame with a pair of spectacle lenses (typically made of plastic or glass) and enclosing shields attached to the sides of the frame to form the chambers. The spectacle lenses may be prescription or non-prescription. The enclosing shields are available in various designs and will fit tightly around the facial contours of the eye sockets. This device is used after an eye operation or for a person with sensitive eyes and/or skin around the eyes.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10193489449471Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489453256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
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