Landers Wide Field Temporary Keratoprosthesis 8.2mm

GUDID 00630238006897

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, reusable

• Primary Device ID: 00630238006897
• NIH Device Record Key: 7d69faf2-3fff-4a56-b322-fb7f1c4f8e78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Landers Wide Field Temporary Keratoprosthesis 8.2mm
• Version Model Number: OLTK 8.2
• 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	00630238006897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910828

FDA Product Code

• MLP: Keratoprosthesis, Temporary Implant, Surgical Use

Sterilization

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

[00630238006897]

Peracetic Acid;Ethylene Oxide

[00630238006897]

Peracetic Acid;Ethylene Oxide

Device Entry Metadata

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

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