Optic Shop

GUDID 20075063012509

Optic Shop Flip-Top Contact Lens Case

PROOPTICS LLC

Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case Contact lens case

• Primary Device ID: 20075063012509
• NIH Device Record Key: 4feb9397-f7d7-4570-93bb-e1278b6bb85e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optic Shop
• Version Model Number: 125
• Company DUNS: 002977189
• Company Name: PROOPTICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	00075063012505 [Primary]
GS1	00075063012512 [Package]; Contains: 00075063012505; Package: [50 Units]; In Commercial Distribution
GS1	20075063012509 [Package]; Contains: 00075063012505; Package: Case [144 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875197

FDA Product Code

• LRX: Case, Contact Lens

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Optic Shop]

• 00075063225127: Optic Shop Tight-Top Contact Lens Case 12-Pack
• 20075063012509: Optic Shop Flip-Top Contact Lens Case