Volk Pictor Plus VP2FA

GUDID 00811608018706

VOLK OPTICAL INC.

Ophthalmic fundus camera

• Primary Device ID: 00811608018706
• NIH Device Record Key: 4be3a426-51fe-4d44-b9cf-db221c071385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volk Pictor Plus VP2FA
• Version Model Number: VP2FA
• 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: false
• Serial Number: true
• 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: 4409426161
• Email: bernie.rykaczewski@volk.com
• Phone: 4409426161
• Email: bernie.rykaczewski@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	00811608018706 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-27
• Device Publish Date: 2016-09-29

Devices Manufactured by VOLK OPTICAL INC.

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• 00811608015934 - Iridectomy (VLUIRID): 2025-02-06
• 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