PDT Laser (VPDT)

GUDID 00811608012483

VOLK OPTICAL INC.

Laser lens, ophthalmic, surgical
Primary Device ID00811608012483
NIH Device Record Keyd119803d-0a15-4639-ae24-19c479c7139a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDT Laser (VPDT)
Version Model NumberVPDT
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 Kitfalse
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
GS100811608012483 [Primary]

FDA Product Code

HJILens, Fundus, Hruby, Diagnostic

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

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