Primary Device ID | 00811608012261 |
NIH Device Record Key | 755860ac-3021-45cc-9c16-4a185695f811 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pictor Prestige - Fundus Kit (VPPHAND and VPPRET) |
Version Model Number | VPPFUNDUSK |
Company DUNS | 071125835 |
Company Name | VOLK OPTICAL INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 | true |
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 | 00811608012261 [Primary] |
HKI | Camera, Ophthalmic, Ac-Powered |
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 |
00811608014760 - 20D Limited Edition | 2024-10-04 |
00811608014777 - 28D Limited Edition | 2024-10-04 |
00811608014784 - Pan Retinal 2.2 Limited Edition | 2024-10-04 |
00811608014791 - Digital ClearField Limited Edition | 2024-10-04 |
00811608014807 - 78D Limited Edition | 2024-10-04 |
00811608014814 - 90D Limited Edition | 2024-10-04 |
00811608014821 - Super 66® Limited Edition | 2024-10-04 |
00811608014838 - SuperField® Limited Edition | 2024-10-04 |