FALLS CREEK

GUDID 00193033028087

FGX INTERNATIONAL INC.

Tinted non-prescription spectacles

• Primary Device ID: 00193033028087
• NIH Device Record Key: 8c4c2e9e-833b-40ba-ab1d-24a652fdd084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FALLS CREEK
• Version Model Number: 10245688.FMR
• 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
• 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	00193033028087 [Primary]

FDA Product Code

• HQY: Sunglasses (non-prescription including photosensitive)

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: 2022-02-07
• Device Publish Date: 2022-01-30

On-Brand Devices [FALLS CREEK]

• 00193033028766: 10246247.FMR
• 00193033028742: 10246253.FMR
• 00193033028728: 10246243.FMR
• 00193033028698: 10246262.FMR
• 00193033028629: 10246257.FMR
• 00193033028599: 10246245.FMR
• 00193033028551: 10246260.FMR
• 00193033028247: 10245722.FMR
• 00193033028179: 10245744.FMR
• 00193033028087: 10245688.FMR
• 00193033028070: 10245680.FMR
• 00193033028063: 10245725.FMR
• 00193033028032: 10245731.FMR
• 00193033027998: 10245746.FMR
• 00193033027943: 10245682.FMR
• 00193033027875: 10245738.FMR
• 00193033027769: 10245732.FMR
• 00193033027493: 10245673.FMR
• 00193033027448: 10245689.FMR
• 00193033027431: 10245690.FMR
• 00193033027424: 10245719.FMR
• 00193033024546: 10245324.FMR
• 00193033024522: 10245325.FMR
• 00887661527394: 10241604.FMR
• 00887661526649: 10241503.FMR
• 00887661526588: 10241499.FMR
• 00887661526564: 10241502.FMR
• 00887661526540: 10241495.FMR
• 00887661525901: 10241271.FMR
• 00887661525895: 10241270.FMR
• 00887661525857: 10241263.FMR
• 00887661525840: 10241262.FMR
• 00887661525833: 10241265.FMR
• 00887661525826: 10241264.FMR
• 00887661525819: 10241258.FMR
• 00887661525802: 10241259.FMR
• 00887661525796: 10241273.FMR
• 00887661525789: 10241272.FMR
• 00887661525758: 10241260.FMR
• 00887661525741: 10241261.FMR
• 00887661525284: 10241236.FMR
• 00887661525277: 10241237.FMR
• 00887661525253: 10241243.FMR
• 00887661525246: 10241238.FMR
• 00887661525239: 10241242.FMR
• 00887661525222: 10241239.FMR
• 00887661525215: 10241240.FMR
• 00887661525208: 10241244.FMR
• 00887661525192: 10241241.FMR
• 00887661522436: 10241253.FMR