Cobo 8.0mm Temporary Keratoprothesis

GUDID 00630238008938

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, reusable

• Primary Device ID: 00630238008938
• NIH Device Record Key: 6b755129-5380-4be9-a9da-91681c09f30e
• Commercial Distribution Discontinuation: 2018-10-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cobo 8.0mm Temporary Keratoprothesis
• Version Model Number: OCTK-8.0
• Company DUNS: 046212387
• Company Name: OCULAR INSTRUMENTS, INC.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630238008938 [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

[00630238008938]

Moist Heat or Steam Sterilization

[00630238008938]

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

Devices Manufactured by OCULAR INSTRUMENTS, INC.

• 00630238081795 - MaxLight® Standard 90D Slit Lamp Indirect Lens (Green): 2021-03-17
• 00630238007122 - Ritch Trabeculoplasty Laser Lens: 2020-02-19
• 00630238122245 - 13063 RxSight 0.766x Mag Contact Lens: 2019-09-19
• 00630238084741 - MaxAC® Lens Stand: 2019-09-10
• 00063023800712 - Ritch Trabeculoplasty Laser Lens: 2019-06-20
• 00630238006972 - Koeppe Extra Small Diagnostic Lens 12mm O.D.: 2019-06-20
• 00630238007092 - Single Mirror Kaufman Laser Lens: 2019-06-20
• 00630238008075 - Koeppe Large Diagnostic Lens 19mm O.D.: 2019-06-20