Disposable Vitrectomy Lense Wide, 10 PK

GUDID 00630238090025

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, single-use

• Primary Device ID: 00630238090025
• NIH Device Record Key: 92758726-7b21-4fcd-a49b-2d4b47a22bf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Vitrectomy Lense Wide, 10 PK
• Version Model Number: ODVW
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630238090025 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-19
• Device Publish Date: 2019-06-11

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