Twisted

GUDID 00812056031415

Eyeglass Frame,"TW101, Black/Orange, 53-17-138"

ENCORE VISION, INC.

Prescription spectacles

• Primary Device ID: 00812056031415
• NIH Device Record Key: a85bcc9e-9fd6-4c4e-8e03-47bb81eef889
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twisted
• Version Model Number: TW101
• Company DUNS: 154402791
• Company Name: ENCORE VISION, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812056031415 [Primary]

FDA Product Code

• HQZ: Frame, Spectacle

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: 2022-06-28
• Device Publish Date: 2022-06-20

On-Brand Devices [Twisted]

• 00812056031521: Eyeglass Frame,"TW202, Purple/Teal, 54-18-140"
• 00812056031514: Eyeglass Frame,"TW202, Black/Fuchsia, 54-18-140"
• 00812056031507: Eyeglass Frame,"TW202, Black/Red, 54-18-140"
• 00812056031491: Eyeglass Frame,"TW201, Purple/Fuchsia, 53-17-140"
• 00812056031484: Eyeglass Frame,"TW201, Brown/Turquoise, 53-17-140"
• 00812056031477: Eyeglass Frame,"TW201, Black/Red, 53-17-140"
• 00812056031460: Eyeglass Frame,"TW102, Grey/Orange, 50-19-138"
• 00812056031453: Eyeglass Frame,"TW102, Black/Silver, 50-19-138"
• 00812056031446: Eyeglass Frame,"TW102, Black/Red, 50-19-138"
• 00812056031439: Eyeglass Frame,"TW101, Blue/Green, 53-17-138"
• 00812056031422: Eyeglass Frame,"TW101, Black/Turquoise, 53-17-138"
• 00812056031415: Eyeglass Frame,"TW101, Black/Orange, 53-17-138"
• 00812056033945: Eyeglass Frame,"TW203, Brown/Turquoise, 54-18-138"
• 00812056033938: Eyeglass Frame,"TW203, Black/Fuchsia, 54-18-138"