Volk Pictor Plus VP2HAND AND VP2RET

GUDID 00811608018614

VOLK OPTICAL INC.

Ophthalmic fundus camera
Primary Device ID00811608018614
NIH Device Record Key57c66c31-d360-4e44-9460-73af1bd1852d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVolk Pictor Plus VP2HAND AND VP2RET
Version Model NumberVP2RETK
Company DUNS071125835
Company NameVOLK OPTICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4404635627
Emailsnigdha.katragadda@volk.com
Phone4404635627
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
GS100811608018614 [Primary]

FDA Product Code

HKICamera, Ophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-24
Device Publish Date2016-09-29

Devices Manufactured by VOLK OPTICAL INC.

00811608014760 - 20D Limited Edition2024-10-04
00811608014777 - 28D Limited Edition2024-10-04
00811608014784 - Pan Retinal 2.2 Limited Edition2024-10-04
00811608014791 - Digital ClearField Limited Edition2024-10-04
00811608014807 - 78D Limited Edition2024-10-04
00811608014814 - 90D Limited Edition2024-10-04
00811608014821 - Super 66® Limited Edition2024-10-04
00811608014838 - SuperField® Limited Edition2024-10-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.