| Primary Device ID | 10850200006572 |
| NIH Device Record Key | 860220ef-c405-42b8-931f-ea2d9e205eec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AORTIC ROOT RETRACTOR |
| Version Model Number | 080260 |
| Catalog Number | 080260 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | true |
| 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(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com | |
| Phone | +1(866)575-3493 |
| regulatorydpt@lsisolutions.com |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Outer Diameter | 26 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850200006575 [Primary] |
| GS1 | 10850200006572 [Package] Contains: 00850200006575 Package: Box [6 Units] In Commercial Distribution |
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2020-03-13 |
| 10850200006572 | AORTIC ROOT RETRACTOR, MEDIUM |
| 10850200006565 | AORTIC ROOT RETRACTOR, LARGE |
| 10850200006558 | AORTIC ROOT RETRACTOR, SMALL |