| Primary Device ID | 20841268102778 |
| NIH Device Record Key | f91ee992-8c2c-49a8-b726-439fc7dda574 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro-Access Elite HV Catheter Introducer Set |
| Version Model Number | CLI-110-24 |
| Catalog Number | CLI-110-24 |
| 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 | 00841268102774 [Primary] |
| GS1 | 10841268102771 [Package] Contains: 00841268102774 Package: Shelf Box [5 Units] In Commercial Distribution |
| GS1 | 20841268102778 [Package] Contains: 10841268102771 Package: Shipper Box [50 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
[20841268102778]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2017-03-21 |
| 20841268108770 | Micro-Access Elite HV Catheter Introducer Set |
| 20841268102792 | Micro-Access Elite HV Catheter Introducer Set |
| 20841268102785 | Micro-Access Elite HV Catheter Introducer Set |
| 20841268102778 | Micro-Access Elite HV Catheter Introducer Set |
| 20841268102761 | Micro-Access Elite HV Catheter Introducer Set |