Disposable Vitrectomy Lens 30°, 10 PK

GUDID 00630238090018

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, single-use

• Primary Device ID: 00630238090018
• NIH Device Record Key: bd8e3bb6-d5c5-4e4b-8dea-980b5c5571b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Vitrectomy Lens 30°, 10 PK
• Version Model Number: ODV3P
• 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	00630238090018 [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

On-Brand Devices [Disposable Vitrectomy Lens 30°, 10 PK]

• 00630238090032: ODV3P
• 00630238090018: ODV3P