| Primary Device ID | 15050474540320 |
| NIH Device Record Key | 4e65b3f0-b9e9-427f-ac87-cf2836a33524 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNFOLDER PLATINUM 1 SERIES |
| Version Model Number | 1MTEC30 |
| Catalog Number | 1MTEC30 |
| 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 | true |
| 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 | +1(877)266-4543 |
| JJV-US-SURGICALORDERS@ITS.JNJ.COM |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05050474540323 [Primary] |
| GS1 | 15050474540320 [Package] Contains: 05050474540323 Package: Box [30 Units] In Commercial Distribution |
| KYB | LENS, GUIDE, INTRAOCULAR |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-26 |
| Device Publish Date | 2019-02-13 |
| 05050474806153 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 05.0D |
| 05050474806160 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 05.5D |
| 05050474806177 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 06.0D |
| 05050474806184 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 06.5D |
| 05050474806191 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 07.0D |
| 05050474806207 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 07.5D |
| 05050474806214 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 08.0D |
| 05050474806221 - PURESEE IOL | 2026-03-24 TECNIS PURESEE SIMPLICITY 08.5D |