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

GUDID 85000713500140

Emerald, tisilfocon A, Blue

EUCLID SYSTEMS CORPORATION

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