Cobo 6.5mm Temporary Keratoprothesis

GUDID 00630238008921

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, reusable

• Primary Device ID: 00630238008921
• NIH Device Record Key: a85b093c-a009-42e4-8c08-b2b350b8bd61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cobo 6.5mm Temporary Keratoprothesis
• Version Model Number: OCTK-6.5
• Company DUNS: 046212387
• Company Name: OCULAR INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630238008921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895013

FDA Product Code

• MLP: Keratoprosthesis, Temporary Implant, Surgical Use

Sterilization

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

[00630238008921]

Moist Heat or Steam Sterilization

[00630238008921]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-17
• Device Publish Date: 2016-12-09

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