G-4 HighMag Small Ring NF

GUDID 00811608013640

VOLK OPTICAL INC.

Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope

• Primary Device ID: 00811608013640
• NIH Device Record Key: dad7db47-976c-4330-ad82-a0f852ad70eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-4 HighMag Small Ring NF
• Version Model Number: VG4HMSNF
• Company DUNS: 071125835
• Company Name: VOLK OPTICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com
• Phone: 440-942-6161
• Email: snigdha.katragadda@volk.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811608013640 [Primary]

FDA Product Code

• HKS: Prism, Gonioscopic

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: 2020-10-05
• Device Publish Date: 2020-09-25

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• 00811608019703 - Virtual by Volk Telemedicine Software: 2021-11-18
• 00811608011240 - Digital Wide Field®, Custom Color: 2021-01-25
• 00811608011332 - Super 66® Stereo Fundus: 2020-10-05