| Primary Device ID | 17290017191000 |
| NIH Device Record Key | 166acd77-b5cd-492d-bf00-f3d697b905db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TroClose1200™ |
| Version Model Number | GSTC1200 |
| Company DUNS | 600087854 |
| Company Name | GORDIAN SURGICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | +1-619-467-3426 |
| TroClose@GordianSurgical.com |
| Length | 115 Millimeter |
| Lumen/Inner Diameter | 12 Millimeter |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017191003 [Primary] |
| GS1 | 17290017191000 [Package] Contains: 07290017191003 Package: [6 Units] In Commercial Distribution |
| GS1 | 27290017191007 [Package] Package: [2 Units] In Commercial Distribution |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-12-07 |
| 27290017191014 | Single Use Cannula with Integrated Port Closure System for use *only* with a TroClose1200™ Obt |
| 17290017191000 | Gordian TroClose1200™ Integrated Port Closure System |