Mounting Kit, Topcon OMS-800

GUDID 00811608019376

VOLK OPTICAL INC.

General-purpose surgical microscope

• Primary Device ID: 00811608019376
• NIH Device Record Key: d23fb81c-7508-44d0-8811-565c7723b58b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mounting Kit, Topcon OMS-800
• Version Model Number: 12162
• 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: true
• 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: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com
• Phone: +1-440-942-6161
• Email: volk@volk.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811608019376 [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: 2025-07-08
• Device Publish Date: 2025-06-30

Devices Manufactured by VOLK OPTICAL INC.

• 00811608019376 - Mounting Kit, Topcon OMS-800: 2025-07-08
• 00811608019376 - Mounting Kit, Topcon OMS-800: 2025-07-08
• 00811608019796 - Mounting Kit, MediWorks SM621: 2025-07-08
• 00811608019765 - Mounting Kit, Alcon Revalia: 2025-04-03
• 00811608019772 - Mounting Kit, Takagi OM-9: 2025-04-03
• 00811608019789 - Mounting Kit, Takagi OM-19: 2025-04-03
• 00811608016115 - Volk SOLR Surgical System: 2025-03-19
• 00811608016122 - Volk SOLR Surgical System 175: 2025-03-19
• 00811608016139 - Volk SOLR Rotation Base: 2025-03-17