UNBRANDED

GUDID 00193033003343

FGX INTERNATIONAL INC.

Tinted non-prescription spectacles

• Primary Device ID: 00193033003343
• NIH Device Record Key: 569a2b54-0556-485e-8aba-75463ff729a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNBRANDED
• Version Model Number: 10244713.COM
• 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	00193033003343 [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 [UNBRANDED]

• 00031568431906: 10206314.FDS
• 00031568431852: 10206343.FDS
• 00031568413278: 10205179.FDS
• 00031568413247: 10205178.FDS
• 00031568413179: 10205175.FDS
• 00031568413018: 10205176.FDS
• 00193033020562: 10245697.COM
• 00193033020555: 10245698.COM
• 00193033010495: 1019588-250.CLC
• 00193033010488: 1019588-200.CLC
• 00193033010471: 1019588-150.CLC
• 00193033010464: 1019587-250.CLC
• 00193033010457: 1019587-200.CLC
• 00193033010440: 1019587-150.CLC
• 00193033010433: 1019586-250.CLC
• 00193033010426: 1019586-200.CLC
• 00193033010419: 1019586-150.CLC
• 00193033010402: 1019585-250.CLC
• 00193033010396: 1019585-200.CLC
• 00193033010389: 1019585-150.CLC
• 00193033010372: 1019584-250.CLC
• 00193033010365: 1019584-200.CLC
• 00193033010358: 1019584-150.CLC
• 00193033010341: 1019583-250.CLC
• 00193033010334: 1019583-200.CLC
• 00193033010327: 1019583-150.CLC
• 00193033010310: 1019582-250.CLC
• 00193033010303: 1019582-200.CLC
• 00193033010297: 1019582-150.CLC
• 00193033010280: 1019581-250.CLC
• 00193033010273: 1019581-200.CLC
• 00193033010266: 1019581-150.CLC
• 00193033010259: 1019580-250.CLC
• 00193033010242: 1019580-200.CLC
• 00193033010235: 1019580-150.CLC
• 00193033010228: 1019579-250.CLC
• 00193033010211: 1019579-200.CLC
• 00193033010204: 1019579-150.CLC
• 00193033003343: 10244713.COM
• 00193033003329: 10244719.COM
• 00193033003312: 10244718.COM
• 00193033002704: 1019456-125.ARM
• 00193033002698: 1019458-125.ARM
• 00193033002490: 1019456-325.ARM
• 00193033002476: 1019458-325.ARM
• 00193033002469: 1019458-275.ARM
• 00193033002452: 1019458-250.ARM
• 00193033002445: 1019458-200.ARM
• 00193033002438: 1019458-150.ARM
• 00193033002360: 1019456-275.ARM