| Primary Device ID | 05050474512993 |
| NIH Device Record Key | fab4b575-e932-47d5-8c4c-085d601646e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BAERVELDT GLAUCOMA IMPLANT (350) |
| Version Model Number | BG101350 |
| Catalog Number | 23030817 |
| Company DUNS | 103021940 |
| Company Name | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| 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 | false |
| Serial Number | true |
| 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 | |
| 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 |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Area/Surface Area | 350 Square millimeter |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 45 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05050474512993 [Primary] |
| KYF | IMPLANT, EYE VALVE |
| 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 | 2015-09-15 |
| 05050474807433 - HEALON PRO | 2024-04-16 HEALON PRO 0,55 ML US |
| 05050474807440 - HEALON PRO | 2024-04-16 HEALON PRO 0,85 ML US |
| 05050474807457 - HEALON GV PRO | 2024-04-16 HEALON GV PRO 0,85 ML US |
| 05050474807464 - HEALON5 PRO | 2024-04-16 HEALON5 PRO 0,6 ML US |
| 05050474812765 - TECNIS ODYSSEY TORIC II IOL | 2024-02-01 TEC ODYSSEY TOR II SMPCY 31.5D CYL3.00 |
| 05050474812888 - TECNIS ODYSSEY TORIC II IOL | 2024-02-01 TEC ODYSSEY TOR II SMPCY 08.0D CYL3.75 |
| 05050474811058 - TECNIS ODYSSEY TORIC II IOL | 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.0D CYL1.50 |
| 05050474811065 - TECNIS ODYSSEY TORIC II IOL | 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.5D CYL1.50 |