Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

GUDID 85000713500201

Kit containing 850007135003 (Emerald, oprificon A, Blue) and 850007135010 (Emerald, oprifocon A, Green)

Euclid Vision Corporation

Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens

• Primary Device ID: 85000713500201
• NIH Device Record Key: 9feacac7-f6ca-4047-889c-e251828524b6
• Commercial Distribution Discontinuation: 2020-02-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
• Version Model Number: Emerald
• Company DUNS: 969263979
• Company Name: Euclid Vision Corporation
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com
• Phone: 1-(800) 477-9396
• Email: UDI@euclidsys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	85000713500201 [Primary]
GS1	85000713599991 [Unit of Use]

FDA Product Code

• NUU: Lens, Contact, Orthokeratology, Overnight

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-04-11
• Device Publish Date: 2019-07-19