20D Limited Edition

GUDID 00811608014760

VOLK OPTICAL INC.

Ophthalmic diagnostic condensing lens
Primary Device ID00811608014760
NIH Device Record Keyfbea6ab6-618d-4942-a2d1-ebcfb2bcd88b
Commercial Distribution StatusIn Commercial Distribution
Brand Name20D Limited Edition
Version Model NumberV20LC-LE
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com
Phone440-942-6161
Emailvolk@volk.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811608014760 [Primary]

FDA Product Code

HJLLens, Condensing, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-04
Device Publish Date2024-09-26

Devices Manufactured by VOLK OPTICAL INC.

00811608014760 - 20D Limited Edition2024-10-04
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.