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

GUDID 85000713500140

Emerald, tisilfocon A, Blue

EUCLID SYSTEMS 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 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: 85000713500140
• NIH Device Record Key: dcad5a0e-4beb-45f6-acad-5db893a98f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
• Version Model Number: Emerald
• Company DUNS: 969263979
• Company Name: EUCLID SYSTEMS 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007135041 [Primary]
GS1	85000713500041 [Package]; Contains: 00850007135041; Package: Deep Well Pillow Pk [1 Units]; In Commercial Distribution
GS1	85000713500140 [Package]; Contains: 00850007135041; Package: Flat Pack Pillow Pk [1 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-03
• Device Publish Date: 2019-07-19

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

• 85000713500195: Emerald Toric, tisilfocon A, Blue
• 85000713500140: Emerald, tisilfocon A, Blue