| Primary Device ID | 50551223000742 |
| NIH Device Record Key | b0bc9b91-1b7c-4a02-b815-cc14af4422a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Auto-shield trocar, ribbed cannula |
| Version Model Number | PS3515 |
| Catalog Number | PS3515 |
| Company DUNS | 239403863 |
| Company Name | PURPLE SURGICAL INTERNATIONAL LIMITED |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | +441923839333 |
| mail@purplesurgical.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05051223000747 [Primary] |
| GS1 | 35051223000748 [Package] Contains: 05051223000747 Package: shelf box [10 Units] In Commercial Distribution |
| GS1 | 50551223000742 [Package] Contains: 35051223000748 Package: shipping carton [40 Units] In Commercial Distribution |
| HET | Laparoscope, Gynecologic (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2016-09-17 |
| 50551223000742 | The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during la |
| 35051223000717 | The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during la |
| 55051223000704 | The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during la |