| Primary Device ID | 20841268105519 |
| NIH Device Record Key | 3db4b657-def4-4cb3-ab61-57d1ddf25ae7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stiffen Micro-Introducer Kit |
| Version Model Number | KIT-011-20 |
| Catalog Number | KIT-011-20 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268105515 [Primary] |
| GS1 | 10841268105512 [Package] Contains: 00841268105515 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268105519 [Package] Contains: 10841268105512 Package: Shipper Box [100 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
[20841268105519]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-02-06 |
| 20841268108787 | Stiffen Micro-Introducer Kit |
| 20841268108718 | Stiffen Micro-Introducer Kit |
| 20841268107360 | Stiffen Micro-Introducer Kit |
| 20841268105687 | Stiffen Micro-Introducer Kit |
| 20841268105670 | Stiffen Micro-Introducer Kit |
| 20841268105663 | Stiffen Micro-Introducer Kit |
| 20841268105656 | Stiffen Micro-Introducer Kit |
| 20841268105649 | Stiffen Micro-Introducer Kit |
| 20841268105632 | Stiffen Micro-Introducer Kit |
| 20841268105625 | Stiffen Micro-Introducer Kit |
| 20841268105618 | Stiffen Micro-Introducer Kit |
| 20841268105601 | Stiffen Micro-Introducer Kit |
| 20841268105595 | Stiffen Micro-Introducer Kit |
| 20841268105588 | Stiffen Micro-Introducer Kit |
| 20841268105571 | Stiffen Micro-Introducer Kit |
| 20841268105564 | Stiffen Micro-Introducer Kit |
| 20841268105557 | Stiffen Micro-Introducer Kit |
| 20841268105540 | Stiffen Micro-Introducer Kit |
| 20841268105533 | Stiffen Micro-Introducer Kit |
| 20841268105526 | Stiffen Micro-Introducer Kit |
| 20841268105519 | Stiffen Micro-Introducer Kit |
| 20841268105502 | Stiffen Micro-Introducer Kit |
| 20841268105496 | Stiffen Micro-Introducer Kit |
| 20841268105489 | Stiffen Micro-Introducer Kit |
| 20841268105472 | Stiffen Micro-Introducer Kit |
| 20841268105465 | Stiffen Micro-Introducer Kit |
| 20841268105458 | Stiffen Micro-Introducer Kit |
| 10841268109794 | Stiffen Micro-Introducer Kit |