Pictor Prestige - Fundus Kit (VPPHAND and VPPRET)

GUDID 00811608012261

VOLK OPTICAL INC.

Ophthalmic fundus camera

• Primary Device ID: 00811608012261
• NIH Device Record Key: 755860ac-3021-45cc-9c16-4a185695f811
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pictor Prestige - Fundus Kit (VPPHAND and VPPRET)
• Version Model Number: VPPFUNDUSK
• Company DUNS: 071125835
• Company Name: VOLK OPTICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• 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	00811608012261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180378

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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

Devices Manufactured by VOLK OPTICAL INC.

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• 00811608019819 - 20D Limited Edition #2: 2025-08-11
• 00811608019826 - 28D Limited Edition #2: 2025-08-11
• 00811608019833 - Pan Retinal 2.2 Limited Edition #2: 2025-08-11
• 00811608019840 - 78D Limited Edition #2: 2025-08-11
• 00811608019857 - 90D Limited Edition #2: 2025-08-11
• 00811608019864 - Super 66® Limited Edition #2: 2025-08-11
• 00811608019871 - SuperField® Limited Edition #2: 2025-08-11