| Primary Device ID | 20841268102792 |
| NIH Device Record Key | d0b9af2f-9d43-4e6c-93c0-7098e6878db9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro-Access Elite HV Catheter Introducer Set |
| Version Model Number | CLI-110-70 |
| Catalog Number | CLI-110-70 |
| 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 | 00841268102798 [Primary] |
| GS1 | 10841268102795 [Package] Contains: 00841268102798 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268102792 [Package] Contains: 10841268102795 Package: Shipper Box [50 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
Ethylene Oxide
[20841268102792]
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 |