Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

GUDID 85000713599991

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

EUCLID SYSTEMS CORPORATION

Orthokeratology contact lens

• Primary Device ID: 85000713599991
• NIH Device Record Key: d4fc2ae3-3f6a-4960-9c20-201b65c097f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
• Version Model Number: Emerald
• Company DUNS: 969263979
• Company Name: EUCLID SYSTEMS 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
• 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
• 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
• 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
• 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	10850007135994 [Primary]
GS1	18500071350206 [Primary]
GS1	85000713599991 [Unit of Use]

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: 2020-03-09
• Device Publish Date: 2020-02-29

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

• 85000713500232: Kit containing 850007135072(Emerald Toric, opirfocon A, Blue) and 850007135089(Emerald Toric, op
• 85000713500225: Kit containing 850007135058 (Emerald Toric, oprifocon A, Blue) and 850007135065 (Emerald Toric,
• 85000713500218: Kit containing 00850007135027 (Emerald, oprifocon A, Blue) and 00850007135034 (Emerald, oprifoco
• 85000713500188: Emerald Toric, oprifocon A, Green
• 85000713500171: Emerald Toric, opirfocon A, Blue
• 85000713500164: Emerald Toric, oprifocon A, Green
• 85000713500157: Emerald Toric, oprifocon A, Blue
• 85000713500133: Emerald, oprifocon A, Green
• 85000713500126: Emerald, oprifocon A, Blue
• 85000713500119: Emerald, oprifocon A, Green
• 85000713500102: Emerald, oprifocon A, Blue
• 85000713599984: Kit containing 850007135027 (Emerald, oprifocon A, Blue) and 850007135034 (Emerald, oprifocon A,
• 85000713599991: Kit containing 850007135003 (Emerald, oprifocon A, Blue) and 850007135010 (Emerald, oprifocon A
• 85000713599960: Kit containing 850007135072 (Emerald Toric, opirfocon A, Blue) and 850007135089 (Emerald Toric,
• 85000713599977: Kit containing 850007135058 (Emerald Toric, oprifocon A, blue) and 850007135065 (Emerald Toric,