ScleralEase

Primary DI
03770020907586
Brand
ScleralEase
Company
ODC INDUSTRIES
Model
4044 SCLE-1
Device description
All-in-One Scleral Lens Application and Removal Tool
Published
2026-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KYEInserter/Remover Contact Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYEInserter/Remover Contact LensOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770020907586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770020907586037700209075863770020907586

GMDN Terms#

Term, Definition table
TermDefinition
Soft contact lens inserter/removerA device designed to insert and remove a soft contact lens from the eye. It typically consists of a small, hand-held, double-prong plastic pincer with specially-designed tips to retract the lens from the eye; the device tip includes a mark and an indentation to hold the lens and facilitate its accurate placement on the eye. The device is used to avoid soft lens contamination and to facilitate lens removal and insertion typically by users with low dexterity, long nails, or rough fingers; it is also used by contact lens wearers in dirty environments. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266454744
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770020907593ScleralEase4045 SCLE-42026-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770020907593ScleralEaseODC INDUSTRIESKYE2026-03-06
B091230120Silicone Suction Cup (10pk)Gulden Ophthalmics Inc.KYE2024-09-04
B091230121Silicone Suction Cup (12 pk)Gulden Ophthalmics Inc.KYE2023-07-05
00840319716632Hayden MedicalHayden Medical, Inc.KYE2022-08-03
00080875971094DMV Scleral CupDMV CORPORATIONKYE2020-04-06
00080875971100DMV Vented Scleral CupDMV CORPORATIONKYE2020-04-06
00080875974231DMV Luma SerterDMV CORPORATIONKYE2020-04-06
00080875974248DMV Luma Serter PlusDMV CORPORATIONKYE2020-04-06
00080875975016DMV TraditionalDMV CORPORATIONKYE2020-04-06
00080875975160DMV Magic TouchDMV CORPORATIONKYE2020-04-06
00080875975290DMV MiniCupDMV CORPORATIONKYE2020-04-06
00080875975863DMV 45DMV CORPORATIONKYE2020-04-06
00080875975955DMV ClassicDMV CORPORATIONKYE2020-04-06
00080875983110DMV Soft Lens HandlerDMV CORPORATIONKYE2020-04-06
00080875985916DMV UltraDMV CORPORATIONKYE2020-04-06
20697660002617Suction Cups (12 units)Oculo-Plastik IncKYE2019-11-08
20697660004604Blue Silicone Suction Cups (100 units)Oculo-Plastik IncKYE2019-11-08
20697660004611Latex-free Rubber Suction Cups (100 units)Oculo-Plastik IncKYE2019-11-08
30697660002256Laser kitOculo-Plastik IncKYE2019-11-07