Single Use Indirect Wide Field (VVITSSVDH)

GUDID 10811608014675

VOLK OPTICAL INC.

Vitrectomy contact lens, single-use

• Primary Device ID: 10811608014675
• NIH Device Record Key: 7c26eec4-00d5-4964-8441-b0710757379a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Indirect Wide Field (VVITSSVDH)
• Version Model Number: VVITSSVDH
• Company DUNS: 071125835
• Company Name: VOLK OPTICAL 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811608014654 [Primary]
GS1	10811608014675 [Package]; Contains: 00811608014654; Package: BOX [10 Units]; In Commercial Distribution
GS1	20811608014689 [Package]; Contains: 00811608014654; Package: CARTON [100 Units]; In Commercial Distribution
GS1	30811608014693 [Package]; Contains: 00811608014654; Package: CASE [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050623

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-27
• Device Publish Date: 2023-10-19

Devices Manufactured by VOLK OPTICAL INC.

• 00811608014760 - 20D Limited Edition: 2024-10-04
• 00811608014777 - 28D Limited Edition: 2024-10-04
• 00811608014784 - Pan Retinal 2.2 Limited Edition: 2024-10-04
• 00811608014791 - Digital ClearField Limited Edition: 2024-10-04
• 00811608014807 - 78D Limited Edition: 2024-10-04
• 00811608014814 - 90D Limited Edition: 2024-10-04
• 00811608014821 - Super 66® Limited Edition: 2024-10-04
• 00811608014838 - SuperField® Limited Edition: 2024-10-04