| Primary Device ID | 00385445083215 |
| NIH Device Record Key | 78241ff0-84a8-49b6-b4fb-fc0fabef5e2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEALON 5 |
| Version Model Number | 10290051 |
| Catalog Number | 10290051 |
| Company DUNS | 103021940 |
| Company Name | JOHNSON & JOHNSON SURGICAL VISION, 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 | true |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385445083215 [Primary] |
| LZP | AID, SURGICAL, VISCOELASTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-26 |
| Device Publish Date | 2014-10-16 |
| 05050474755093 - HEALON ENDOCOAT PRO | 2025-08-28 HEALON ENDOCOAT PRO 0,85 ML USA |
| 05050474755116 - HEALON DUET PRO II | 2025-08-28 HEALON DUET PRO II US |
| 05050474829572 - SMARTLOAD | 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 5.0D |
| 05050474829589 - SMARTLOAD | 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 5.5D |
| 05050474829596 - SMARTLOAD | 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 6.0D |
| 05050474829602 - SMARTLOAD | 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 6.5D |
| 05050474829619 - SMARTLOAD | 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 7.0D |
| 05050474829626 - SMARTLOAD | 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 7.5D |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEALON 5 75766308 2716012 Live/Registered |
AMO UPPSALA AB 1999-08-02 |