| Primary Device ID | 00853480006136 |
| NIH Device Record Key | 8baf9317-8a69-44a5-9a9e-b93601129528 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrigating Contact Lens |
| Version Model Number | Flat |
| Catalog Number | TR9840-11 |
| Company DUNS | 879144426 |
| Company Name | ESCALON MEDICAL CORP. |
| 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 | 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 | 800-486-4848 |
| info@escalonmed.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853480006136 [Primary] |
| KYG | Device, Irrigation, Ocular Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-01-14 |
| 00853480006143 | For use during silicone oil procedures, irrigating contact lens enables visualization of surgica |
| 00853480006136 | For use during silicone oil procedures, irrigating contact lens enables visualization of surgica |