Deep Well Lens Case (Ribbed)

Basic Information

• Brand Name: Deep Well Lens Case (Ribbed)
• Primary DI: B222600
• Version / Model: 600
• Company Name: Paragon Vision Sciences, Inc.
• Labeler DUNS: 028594987
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2017-12-08
• Public Version: 3
• Public Version Date: 2021-03-23
• Public Version Status: Update
• Public Device Record Key: 2861bf2f-e913-4562-bd2a-7d80f71fc39c

Device Description

Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have a ribbed lens well surface. They are used for the storage and chemical disinfection of hard, GP or soft contact lenses. They are not to be used with heat disinfection.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LRX	Case, Contact Lens	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16581	Contact lens case	A container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B222600	HIBCC
Unit of Use	B2226009	HIBCC