| Primary Device ID | 20841268108770 |
| NIH Device Record Key | a6f54807-a588-4411-87a2-b8da1ca07027 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro-Access Elite HV Catheter Introducer Set |
| Version Model Number | CLI-112-00 |
| Catalog Number | CLI-112-00 |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com |
| Catheter Gauge | 4 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268108776 [Primary] |
| GS1 | 10841268108773 [Package] Contains: 00841268108776 Package: Shelf Box [5 Units] In Commercial Distribution |
| GS1 | 20841268108770 [Package] Contains: 10841268108773 Package: Shipper Box [50 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268108770]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2019-05-28 |
| 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 |