| Primary Device ID | 10841268109794 |
| NIH Device Record Key | 7221735a-b4d7-4eac-aa43-6b80221ea3d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stiffen Micro-Introducer Kit |
| Version Model Number | KIT-076-02 |
| Catalog Number | KIT-076-02 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109797 [Primary] |
| GS1 | 10841268109794 [Package] Contains: 00841268109797 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109791 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
Ethylene Oxide
[10841268109794]
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 |
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| 20841268105465 | Stiffen Micro-Introducer Kit |
| 20841268105458 | Stiffen Micro-Introducer Kit |
| 10841268109794 | Stiffen Micro-Introducer Kit |