Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear Emerald Toric

GUDID 00850007135546

Kit containing 1x 00850007135065 (Emerald Toric, oprifocon A, Green) China Distribution; Alternate Trials: Emerald Toric Trial, Emerald Advance Toric Trial, Emerald Toric Essential Toric Trial; Alternate Trial Models: CHN010-11-T1, CHN004-11-T1, CHN008-11-T1

Euclid Vision Corporation

Orthokeratology contact lens

• Primary Device ID: 00850007135546
• NIH Device Record Key: 251146ea-5d16-4950-adb5-25feb0eabb79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
• Version Model Number: CHN010-11-P1
• Catalog Number: Emerald Toric
• Company DUNS: 969263979
• Company Name: Euclid Vision Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007135546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040029

FDA Product Code

• NUU: Lens, Contact, Orthokeratology, Overnight

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

On-Brand Devices [Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear]

• 85000713500201: Kit containing 850007135003 (Emerald, oprificon A, Blue) and 850007135010 (Emerald, oprifocon A,
• 85000713501529: Kit containing 2x 00850007135065 (Emerald Toric, oprifocon A, Green) China Distribution
• 85000713501512: Kit containing 2x 00850007135058 (Emerald Toric, oprifocon A, Blue) China Distribution
• 85000713501475: Kit containing 2x 00850007135010 (Emerald, oprifocon A, Green) China Distribution
• 85000713501468: Kit containing 2x 00850007135003 (Emerald, oprifocon A, Blue) China Distribution
• 10850007135611: Kit containing 00850007135003 (Emerald, oprifocon A, Blue) and 00850007135010 (Emerald, oprifoco
• 10850007135604: Kit containing 00850007135058 (Emerald Toric, oprifocon A, Blue) and 00850007135065 (Emerald Tor
• 10840162099996: Kit containing 1x 00850007135003 (Emerald, oprifocon A, Blue) China Distribution
• 10840162099989: Kit containing 1x 00850007135010 (Emerald Advance, oprifocon A, Green) China Distribution
• 10840162099972: Kit containing 1x 00850007135058 (Emerald Advance Toric, oprifocon A, Blue) China Distribution
• 10840162099965: Kit containing 1x 00850007135065 (Emerald Advance Toric, oprifocon A, Green) China Distribution
• 10840162000350: Kit containing 00850007135058 (Emerald Essential Toric, oprifocon A, Blue) and 00850007135065 (E
• 10840162000343: Kit containing 00850007135058 (Emerald Advance Toric, oprifocon A, Blue) and 00850007135065 (Eme
• 10840162000336: Kit containing 00850007135003 (Emerald Essential, oprifocon A, Blue) and 00850007135010 (Emerald
• 10840162000329: Kit containing 00850007135003 (Emerald Advance, oprifocon A, Blue) and 00850007135010 (Emerald A
• 10840162000312: Kit containing 2x 00850007135065 (Emerald Essential Toric, oprifocon A, Green) China Distributio
• 10840162000305: Kit containing 2x 00850007135065 (Emerald Advance Toric, oprifocon A, Green) China Distribution
• 10840162000299: Kit containing 2x 00850007135058 (Emerald Essential Toric, oprifocon A, Blue) China Distribution
• 10840162000282: Kit containing 2x 00850007135058 (Emerald Advance Toric, oprifocon A, Blue) China Distribution
• 10840162000275: Kit containing 2x 00850007135010 (Emerald Essential, oprifocon A, Green) China Distribution
• 10840162000268: Kit containing 2x 00850007135010 (Emerald Advance, oprifocon A, Green) China Distribution
• 10840162000251: Kit containing 2x 00850007135003 (Emerald Essential, oprifocon A, Blue) China Distribution
• 10840162000244: Kit containing 2x 00850007135003 (Emerald Advance, oprifocon A, Blue) China Distribution
• 10840162000213: Kit containing 1x 00850007135065 (Emerald Essential Toric, oprifocon A, Green) China Distributio
• 10840162000206: Kit containing 1x 00850007135058 (Emerald Essential Toric, oprifocon A, Blue) China Distribution
• 10840162000190: Kit containing 1x 00850007135010 (Emerald Essential, oprifocon A, Green) China Distribution
• 10840162000183: Kit containing 1x 00850007135003 (Emerald Essential, oprifocon A, Blue) China Distribution
• 00850007135546: Kit containing 1x 00850007135065 (Emerald Toric, oprifocon A, Green) China Distribution; Alterna
• 00850007135539: Kit containing 1x 00850007135058 (Emerald Toric, oprifocon A, Blue) China Distribution; Alternat
• 00850007135522: Kit containing 1x 00850007135010 (Emerald, oprifocon A, Green) China Distribution; Alternate Tri
• 00850007135515: Kit containing 1x 00850007135003 (Emerald, oprifocon A, Blue) China Distribution; Alternate Tria