Primary Device ID | 00811608013749 |
NIH Device Record Key | e2028880-bd91-4592-8024-8058fb27d332 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROLS Reinverter - Zeiss + |
Version Model Number | VROLS-Z+ |
Company DUNS | 071125835 |
Company Name | VOLK OPTICAL INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
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 | false |
OTC Over-The-Counter | false |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com | |
Phone | 440-942-6161 |
snigdha.katragadda@volk.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811608013749 [Primary] |
FSO | Microscope, Surgical, General & Plastic Surgery |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-05 |
Device Publish Date | 2020-09-25 |
00811608014708 - Volk Viva | 2024-04-15 |
00811608014739 - Volk Viva | 2024-04-15 |
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 |