| Primary Device ID | 05391526210017 |
| NIH Device Record Key | 5a8ebe36-461f-4570-b582-f87e857073a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gore TIPS® Sheath |
| Version Model Number | TSTH1040 |
| Catalog Number | TSTH1040 |
| Company DUNS | 985218606 |
| Company Name | CREGANNA UNLIMITED COMPANY |
| 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 |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Catheter Gauge | 10 French |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391526210017 [Primary] |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-09-23 |
| 05391526210154 - Trapper™ Exchange Device | 2019-10-07 Trapper™ Exchange Device |
| 05391526210017 - Gore TIPS® Sheath | 2019-06-07Gore TIPS® Sheath |
| 05391526210017 - Gore TIPS® Sheath | 2019-06-07 Gore TIPS® Sheath |
| 05391526210109 - Lotus™ Introducer Set | 2019-06-07 Lotus™ Introducer Set, Small |
| 05391526210116 - Lotus™ Introducer Set | 2019-06-07 Lotus™ Introducer Set, Large |
| 05391526210253 - Attain Assist™ CS Access Catheter | 2019-02-14 Attain Assist™ CS Access Catheter |
| 05391526210031 - Zurpaz™ Steerable Sheath Set | 2019-01-23 Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath |
| 05391526210048 - Zurpaz™ Steerable Sheath Set | 2019-01-23 Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath |
| 05391526210055 - Zurpaz™ Steerable Sheath Set | 2019-01-23 Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath |