| Primary Device ID | 55051223015197 |
| NIH Device Record Key | 63289159-2eb7-4db5-9241-5d5363baa424 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultimate Dilating tip trocar with smooth cannula plus extra cannula |
| Version Model Number | PS4461ULT |
| Catalog Number | PS4461ULT |
| 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 | 05051223015192 [Primary] |
| GS1 | 35051223015193 [Package] Contains: 05051223015192 Package: inner box [5 Units] In Commercial Distribution |
| GS1 | 55051223015197 [Package] Contains: 35051223015193 Package: shipping carton [20 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 |
| 05051223015222 | The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to e |
| 55051223015197 | The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to e |