Optic Shop

GUDID 20075063012509

Optic Shop Flip-Top Contact Lens Case

PROOPTICS LLC

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