DESIGN OPTICS

GUDID 00193033010716

FGX INTERNATIONAL INC.

Prescription spectacles

• Primary Device ID: 00193033010716
• NIH Device Record Key: 09181004-986d-4f93-966c-befe42e28261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DESIGN OPTICS
• Version Model Number: 5011563-250.CSC
• Company DUNS: 062312087
• Company Name: FGX INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com
• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com
• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com
• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com
• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com
• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com
• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193033010716 [Primary]

FDA Product Code

• HOI: Spectacle, magnifying

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: 2022-07-06
• Device Publish Date: 2022-06-28

On-Brand Devices [DESIGN OPTICS]

• 00887661604279: 1019254-275.CSC
• 00887661604248: 1019254-175.CSC
• 00887661604187: 1019255-300.CSC
• 00887661604170: 1019255-275.CSC
• 00887661604163: 1019255-250.CSC
• 00887661604156: 1019255-200.CSC
• 00887661604149: 1019255-175.CSC
• 00887661604132: 1019255-150.CSC
• 00887661604125: 1019255-125.CSC
• 00887661590503: 1018116-275.CSC
• 00887661590480: 1018114-275.CSC
• 00887661543608: ARD48-150.CSC
• 00887661377982: 1018116-200.CSC
• 00887661377975: 1018116-175.CSC
• 00887661377951: 1018116-125.CSC
• 00887661377883: 1018114-300.CSC
• 00887661377876: 1018114-250.CSC
• 00887661377869: 1018114-200.CSC
• 00887661377845: 1018114-150.CSC
• 00887661377838: 1018114-125.CSC
• 00193033393604: 5012006-300.CSC
• 00193033393598: 5012006-275.CSC
• 00193033393581: 5012006-250.CSC
• 00193033393567: 5012006-200.CSC
• 00193033393550: 5012006-175.CSC
• 00193033393543: 5012006-150.CSC
• 00193033393536: 5012006-125.CSC
• 00193033393512: 5012008-300.CSC
• 00193033393505: 5012008-275.CSC
• 00193033393499: 5012008-250.CSC
• 00193033393475: 5012008-200.CSC
• 00193033393468: 5012008-175.CSC
• 00193033393451: 5012008-150.CSC
• 00193033393444: 5012008-125.CSC
• 00193033393437: 5012007-300.CSC
• 00193033393420: 5012007-275.CSC
• 00193033393413: 5012007-250.CSC
• 00193033393390: 5012007-200.CSC
• 00193033393383: 5012007-175.CSC
• 00193033393376: 5012007-150.CSC
• 00193033393369: 5012007-125.CSC
• 00193033393352: 5012005-300.CSC
• 00193033393345: 5012005-275.CSC
• 00193033393338: 5012005-250.CSC
• 00193033393314: 5012005-200.CSC
• 00193033393307: 5012005-175.CSC
• 00193033393291: 5012005-150.CSC
• 00193033393284: 5012005-125.CSC
• 00193033360996: 5011555-125.CSC
• 00193033360927: 5011552-125.CSC