| Primary Device ID | 10841268109640 |
| NIH Device Record Key | 31b823ec-9eb2-4811-badf-2447f4bb4f0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tearaway Sheath Introducer |
| Version Model Number | INT-117-16 |
| Catalog Number | INT-117-16 |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Catheter Gauge | 16 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109643 [Primary] |
| GS1 | 10841268109640 [Package] Contains: 00841268109643 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109647 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
[10841268109640]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-08 |
| Device Publish Date | 2021-10-29 |
| 10841268110134 - Guidewire | 2024-08-09 Guidewire |
| 10841268109800 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109817 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109824 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109831 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109848 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109855 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |
| 10841268109862 - Elite Transitionless Micro-Introducer Kit | 2022-08-23 Elite Transitionless Micro-Introducer Kit |