ScleralEase

Basic Information

• Brand Name: ScleralEase
• Primary DI: 03770020907593
• Version / Model: 4045 SCLE-4
• Company Name: ODC INDUSTRIES
• Labeler DUNS: 266454744
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2026-03-06
• Public Version: 2
• Public Version Date: 2026-03-30
• Public Version Status: Update
• Public Device Record Key: e30b4682-b74c-489c-9f7f-2ab836819ce8

Device Description

All-in-One Scleral Lens Application and Removal Tool

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYE	Inserter/Remover Contact Lens	Ophthalmic	886.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42810	Rigid contact lens inserter/remover	A device designed to insert and remove hard and semi-rigid contact lenses from the eye. It typically consists of a small, hand-held device that has a handle and a concave cup-like distal end; some devices include a vented handle that provides manually-adjustable suction for lens removal. The device is used to avoid hard and semi-rigid 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03770020907593	GS1
Unit of Use	03770020907555	GS1