Primary Device ID | 25391526210028 |
NIH Device Record Key | e313ce29-6d7e-450d-8017-1b383bcf6a94 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Gore TIPS Set |
Version Model Number | TSET1016 |
Catalog Number | TSET1016 |
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 |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
Catheter Gauge | 10 French |
Needle Gauge | 16 Gauge |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 25391526210028 [Primary] |
DYB | Introducer, Catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-23 |
05391526210154 - Trapper™ Exchange Device | 2019-10-07 Trapper™ Exchange Device |
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 |