| Primary Device ID | 10841268109855 |
| NIH Device Record Key | 3db39fc5-26c1-40d9-a6d6-50a880920155 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elite Transitionless Micro-Introducer Kit |
| Version Model Number | KIT-098-06 |
| Catalog Number | KIT-098-06 |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109858 [Primary] |
| GS1 | 10841268109855 [Package] Contains: 00841268109858 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109852 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
[10841268109855]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-23 |
| Device Publish Date | 2022-08-15 |
| 10841268110035 | Elite Transitionless Micro-Introducer Kit |
| 10841268110028 | Elite Transitionless Micro-Introducer Kit |
| 10841268110011 | Elite Transitionless Micro-Introducer Kit |
| 10841268110004 | Elite Transitionless Micro-Introducer Kit |
| 10841268109992 | Elite Transitionless Micro-Introducer Kit |
| 10841268109985 | Elite Transitionless Micro-Introducer Kit |
| 10841268109978 | Elite Transitionless Micro-Introducer Kit |
| 10841268109961 | Elite Transitionless Micro-Introducer Kit |
| 10841268109954 | Elite Transitionless Micro-Introducer Kit |
| 10841268109947 | Elite Transitionless Micro-Introducer Kit |
| 10841268109930 | Elite Transitionless Micro-Introducer Kit |
| 10841268109923 | Elite Transitionless Micro-Introducer Kit |
| 10841268109916 | Elite Transitionless Micro-Introducer Kit |
| 10841268109909 | Elite Transitionless Micro-Introducer Kit |
| 10841268109893 | Elite Transitionless Micro-Introducer Kit |
| 10841268109886 | Elite Transitionless Micro-Introducer Kit |
| 10841268109879 | Elite Transitionless Micro-Introducer Kit |
| 10841268109862 | Elite Transitionless Micro-Introducer Kit |
| 10841268109855 | Elite Transitionless Micro-Introducer Kit |
| 10841268109848 | Elite Transitionless Micro-Introducer Kit |
| 10841268109831 | Elite Transitionless Micro-Introducer Kit |
| 10841268109824 | Elite Transitionless Micro-Introducer Kit |
| 10841268109817 | Elite Transitionless Micro-Introducer Kit |
| 10841268109800 | Elite Transitionless Micro-Introducer Kit |