Primary Device ID | 893872001462 |
NIH Device Record Key | aac518e9-bf29-4a60-bef4-27c2721d9fc8 |
Commercial Distribution Discontinuation | 2017-11-30 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | iCAP Imaging Cap |
Version Model Number | IC-100 |
Catalog Number | 200549 |
Company DUNS | 079755637 |
Company Name | Nova Eye, Inc. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com | |
Phone | 1-888-846-4724 |
canaloplasty@ellex.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00893872001028 [Primary] |
GS1 | 893872001462 [Package] Contains: 00893872001028 Package: Multiple Unit Box [15 Units] Discontinued: 2017-11-30 Not in Commercial Distribution |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-12-08 |
Device Publish Date | 2016-09-19 |
00893872001608 - iLumin | 2024-07-29 Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions |
00893872001622 - iTrack Advance | 2023-04-12 Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2 |
893872001462 - iCAP Imaging Cap | 2020-12-08Imaging Cap |
893872001462 - iCAP Imaging Cap | 2020-12-08 Imaging Cap |
00893872001585 - ViscoInjector | 2020-12-08 Opthalmic Viscoelastic Injector |