| Primary Device ID | 10841268109619 |
| NIH Device Record Key | b28bc0a8-0697-4ef4-a5e6-c31577b58f40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro-Introducer Kit |
| Version Model Number | KIT-096-00 |
| Catalog Number | KIT-096-00 |
| 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 | 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 | 00841268109612 [Primary] |
| GS1 | 10841268109619 [Package] Contains: 00841268109612 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109616 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
Ethylene Oxide
[10841268109619]
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 |
| 20841268108763 | Micro-Introducer Kit |
| 20841268108701 | Micro-Introducer Kit |
| 20841268107803 | Micro-Introducer Kit |
| 20841268107216 | Micro-Introducer Kit |
| 20841268107209 | Micro-Introducer Kit |
| 20841268107193 | Micro-Introducer Kit |
| 20841268107186 | Micro-Introducer Kit |
| 20841268106936 | Micro-Introducer Kit |
| 20841268106929 | Micro-Introducer Kit |
| 20841268104970 | Micro-Introducer Kit |
| 20841268104963 | Micro-Introducer Kit |
| 20841268104956 | Micro-Introducer Kit |
| 20841268104949 | Micro-Introducer Kit |
| 20841268104932 | Micro-Introducer Kit |
| 20841268104925 | Micro-Introducer Kit |
| 20841268104918 | Micro-Introducer Kit |
| 20841268104901 | Micro-Introducer Kit |
| 20841268104895 | Micro-Introducer Kit |
| 20841268104888 | Micro-Introducer Kit |
| 20841268104871 | Micro-Introducer Kit |
| 20841268104864 | Micro-Introducer Kit |
| 20841268104857 | Micro-Introducer Kit |
| 20841268104840 | Micro-Introducer Kit |
| 20841268104833 | Micro-Introducer Kit |
| 20841268104826 | Micro-Introducer Kit |
| 20841268104819 | Micro-Introducer Kit |
| 20841268104802 | Micro-Introducer Kit |
| 20841268104796 | Micro-Introducer Kit |
| 20841268104789 | Micro-Introducer Kit |
| 20841268104772 | Micro-Introducer Kit |
| 20841268104765 | Micro-Introducer Kit |
| 20841268104758 | Micro-Introducer Kit |
| 20841268104741 | Micro-Introducer Kit |
| 20841268104734 | Micro-Introducer Kit |
| 20841268104727 | Micro-Introducer Kit |
| 20841268104710 | Micro-Introducer Kit |
| 20841268104703 | Micro-Introducer Kit |
| 20841268104697 | Micro-Introducer Kit |
| 20841268104680 | Micro-Introducer Kit |
| 20841268104673 | Micro-Introducer Kit |
| 20841268104666 | Micro-Introducer Kit |
| 20841268104659 | Micro-Introducer Kit |
| 20841268104642 | Micro-Introducer Kit |
| 20841268104628 | Micro-Introducer Kit |
| 20841268104611 | Micro-Introducer Kit |
| 20841268104604 | MIcro-Introducer Kit |
| 20841268104420 | Micro-Introducer Kit |
| 20841268102815 | Micro-Introducer Kit |
| 20841268102808 | Micro-Introducer Kit |
| 10841268109619 | Micro-Introducer Kit |