| Primary Device ID | 05050474709508 |
| NIH Device Record Key | 23c9682f-1077-4c8c-9522-f04a9d6f660b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CATALYS SYSTEM |
| Version Model Number | 0160-9500 |
| Catalog Number | 0160-9500 |
| Company DUNS | 151018996 |
| Company Name | OPTIMEDICA CORPORATION |
| 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 | 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 | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM | |
| Phone | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05050474709508 [Primary] |
| OOE | Ophthalmic femtosecond laser |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-27 |
| Device Publish Date | 2020-08-19 |
| 05050474609792 | CATALYS SYSTEM, US |
| 05050474709508 | CATALYS ELEVATED SYS ACCY,USE W/MPB,US |