| Primary Device ID | 10841268109763 |
| NIH Device Record Key | c4e1b94b-fa09-4db5-906b-4d517f4c43cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tearaway Introducer Set |
| Version Model Number | INT-128-15 |
| Catalog Number | INT-128-15 |
| 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 | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109766 [Primary] |
| GS1 | 10841268109763 [Package] Contains: 00841268109766 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109760 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
[10841268109763]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-27 |
| Device Publish Date | 2022-04-19 |
| 20841268108855 | Tearaway Introducer Set |
| 20841268108848 | Tearaway Introducer Set |
| 20841268108695 | Tearaway Introducer Set |
| 20841268108824 | Tearaway Introducer Set |
| 20841268108817 | Tearaway Introducer Set |
| 20841268107384 | Tearaway Introducer Set |
| 20841268107223 | Tearaway Introducer Set |
| 20841268102976 | Tearaway Introducer Set |
| 20841268102969 | Tearaway Introducer Set |
| 00841268102590 | Tearaway Introducer Set |
| 00841268102583 | Tearaway Introducer Set |
| 00841268102576 | Tearaway Introducer Set |
| 00841268102569 | Tearaway Introducer Set |
| 20841268102402 | Tearaway Introducer Set |
| 20841268102396 | Tearaway Introducer Set |
| 20841268102389 | Tearaway Introducer Set |
| 20841268102372 | Tearaway Introducer Set |
| 20841268102365 | Tearaway Introducer Set |
| 20841268102358 | Tearaway Introducer Set |
| 20841268102341 | Tearaway Introducer Set |
| 20841268102334 | Tearaway Introducer Set |
| 20841268102327 | Tearaway Introducer Set |
| 20841268102310 | Tearaway Introducer Set |
| 20841268102303 | Tearaway Introducer Set |
| 20841268102297 | Tearaway Introducer Set |
| 20841268102280 | Tearaway Introducer Set |
| 20841268102273 | Tearaway Introducer Set |
| 20841268102266 | Tearaway Introducer Set |
| 20841268102259 | Tearaway Introducer Set |
| 20841268102242 | Tearaway Introducer Set |
| 20841268102235 | Tearaway Introducer Set |
| 20841268102228 | Tearaway Introducer Set |
| 20841268102211 | Tearaway Introducer Set |
| 20841268102204 | Tearaway Introducer Set |
| 20841268102198 | Tearaway Introducer Set |
| 20841268102181 | Tearaway Introducer Set |
| 20841268102174 | Tearaway Introducer Set |
| 20841268102167 | Tearaway Introducer Set |
| 20841268102150 | Tearaway Introducer Set |
| 20841268102143 | Tearaway Introducer Set |
| 20841268102136 | Tearaway Introducer Set |
| 20841268102129 | Tearaway Introducer Set |
| 20841268102112 | Tearaway Introducer Set |
| 20841268102105 | Tearaway Introducer Set |
| 20841268102099 | Tearaway Introducer Set |
| 20841268102082 | Tearaway Introducer Set |
| 20841268102075 | Tearaway Introducer Set |
| 20841268102068 | Tearaway Introducer Set |
| 20841268102051 | Tearaway Introducer Set |
| 20841268102044 | Tearaway Introducer Set |