Disposable Biconcave Vitrectomy

GUDID 00630238075206

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, single-use

• Primary Device ID: 00630238075206
• NIH Device Record Key: 9eeb7a24-8871-49c6-8623-5d7f3a7362f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Biconcave Vitrectomy
• Version Model Number: ODVB 12183
• Company DUNS: 046212387
• Company Name: OCULAR INSTRUMENTS, INC.
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00063023812183 [Unit of Use]
GS1	00630238075206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012096

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-09

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