UNBRANDED

GUDID 00031568657436

FGX INTERNATIONAL INC.

Prescription spectacles

• Primary Device ID: 00031568657436
• NIH Device Record Key: 7fd6faa8-f3ae-4de0-854a-0ab708abbb08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNBRANDED
• Version Model Number: 5014216-125.CGU
• 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
• Phone: +1(401)231-3800
• Email: Customerservices@fgxi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00031568657436 [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: 2022-10-19
• Device Publish Date: 2022-10-11

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• 00031568431852: 10206343.FDS
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• 00031568413179: 10205175.FDS
• 00031568413018: 10205176.FDS
• 00193033020562: 10245697.COM
• 00193033020555: 10245698.COM
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• 00193033010488: 1019588-200.CLC
• 00193033010471: 1019588-150.CLC
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• 00193033010457: 1019587-200.CLC
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• 00193033003343: 10244713.COM
• 00193033003329: 10244719.COM
• 00193033003312: 10244718.COM
• 00193033002704: 1019456-125.ARM
• 00193033002698: 1019458-125.ARM
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• 00193033002476: 1019458-325.ARM
• 00193033002469: 1019458-275.ARM
• 00193033002452: 1019458-250.ARM
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• 00193033002360: 1019456-275.ARM