Pictor Prestige - Full Kit (VPPHAND, VPPRET and VPPANT)

GUDID 00811608012254

VOLK OPTICAL INC.

Ophthalmic fundus camera
Primary Device ID00811608012254
NIH Device Record Key966e9f1b-8560-4d32-8f92-7a708ad4c055
Commercial Distribution StatusIn Commercial Distribution
Brand NamePictor Prestige - Full Kit (VPPHAND, VPPRET and VPPANT)
Version Model NumberVPPFULLK
Company DUNS071125835
Company NameVOLK OPTICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com
Phone440-942-6161
Emailsnigdha.katragadda@volk.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811608012254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKICamera, Ophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

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00811608014838 - SuperField® Limited Edition2024-10-04

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