Pictor Prestige - Fundus Kit (VPPHAND and VPPRET)

GUDID 00811608012261

VOLK OPTICAL INC.

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera 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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• 10811608014675 - Single Use Indirect Wide Field (VVITSSVDH): 2023-10-27
• 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