Merlin Mount, Topcon

GUDID 00811608017556

VOLK OPTICAL INC.

General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope

• Primary Device ID: 00811608017556
• NIH Device Record Key: caf54dbc-fac5-4366-bc38-e14baf9dbe43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merlin Mount, Topcon
• Version Model Number: 11413
• 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	00811608017556 [Primary]

FDA Product Code

• FSO: Microscope, Surgical, General & Plastic Surgery

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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• 00811608013770 - Volk VistaView: 2022-11-24
• 00811608014586 - VistaView Slit Lamp Adapter: 2022-11-24
• 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