iLumin 200529
GUDID 00893872001073
Optical Light Source- Fiberoptic Illuminator
ELLEX ISCIENCE
Ophthalmic infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit Ophthalmic procedural light source unit| Primary Device ID | 00893872001073 |
| NIH Device Record Key | 745d58ab-90e5-4f74-bc64-29f15de460dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iLumin |
| Version Model Number | FI-100 |
| Catalog Number | 200529 |
| Company DUNS | 079755637 |
| Company Name | ELLEX ISCIENCE |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| 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 | |
| Phone | 1-888-846-4724 |
| canaloplasty@ellex.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com | |
| Phone | 1-510-291-1300 |
| iTrack@nova-eye.com |
Device Dimensions
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
| Height | 8 Inch |
| Length | 14 Inch |
| Weight | 3.048 Pound |
| Height | 4 Inch |
| Width | 7 Inch |
| Depth | 4.5 Inch |
Operating and Storage Conditions
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893872001073 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062259
FDA Product Code
| MPA | Endoilluminator |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-09-15 |
Devices Manufactured by ELLEX ISCIENCE
| 00893872001059 - iTrack 250A | 2019-04-23 Canaloplasty Microcatheter Kit Kit Contents: (1) Canaloplasty Microcatheter iTrack 250A (1) Opthalmic Viscoinjector |
| 00893872001073 - iLumin | 2019-04-23Optical Light Source- Fiberoptic Illuminator |
| 00893872001073 - iLumin | 2019-04-23 Optical Light Source- Fiberoptic Illuminator |
Trademark Results [iLumin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ILUMIN 97241924 not registered Live/Pending |
Ilumin 2022-01-27 |
 ILUMIN 90249282 not registered Live/Pending |
Gregorio Dynasty Inc. 2020-10-12 |
 ILUMIN 88524650 not registered Live/Pending |
Inovelli, LLC 2019-07-19 |
 ILUMIN 75602697 2847612 Dead/Cancelled |
ILUMIN SOFTWARE SERVICES, INC. 1998-12-10 |
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