| Primary Device ID | 20841268104413 |
| NIH Device Record Key | a0caa79b-455b-40c7-ae74-f95c5028a75b |
| Commercial Distribution Discontinuation | 2019-06-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Elite HV Introducer Set |
| Version Model Number | CLI-608-07 |
| Catalog Number | CLI-608-07 |
| 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 | 7 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268104419 [Primary] |
| GS1 | 10841268104416 [Package] Contains: 00841268104419 Package: Shelf Box [5 Units] Discontinued: 2019-06-27 Not in Commercial Distribution |
| GS1 | 20841268104413 [Package] Contains: 10841268104416 Package: Shipper Box [25 Units] Discontinued: 2019-06-27 Not in Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268104413]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2018-02-26 |
| 20841268104413 | Elite HV Introducer Set |
| 20841268104161 | Elite HV Introducer Set |
| 20841268104154 | Elite HV Introducer Set |
| 20841268104147 | Elite HV Introducer Set |
| 20841268103447 | Elite HV Introducer Set |
| 20841268103430 | Elite HV Introducer Set |
| 20841268103423 | Elite HV Introducer Set |
| 20841268103416 | Elite HV Introducer Set |
| 20841268103409 | Elite HV Introducer Set |
| 20841268103393 | Elite HV Introducer Set |
| 20841268103386 | Elite HV Introducer Set |
| 20841268103379 | Elite HV Introducer Set |
| 20841268103362 | Elite HV Introducer Set |
| 20841268103355 | Elite HV Introducer Set |
| 20841268103348 | Elite HV Introducer Set |
| 20841268103331 | Elite HV Introducer Set |
| 20841268103164 | Elite HV Introducer Set |
| 20841268103157 | Elite HV Introducer Set |
| 20841268103140 | Elite HV Introducer Set |
| 20841268103133 | Elite HV Introducer Set |
| 20841268103126 | Elite HV Introducer Set |
| 20841268103119 | Elite HV Introducer Set |
| 20841268103102 | Elite HV Introducer Set |
| 20841268103096 | Elite HV Introducer Set |
| 20841268103089 | Elite HV Introducer Set |
| 20841268103072 | Elite HV Introducer Set |
| 00841268103061 | Elite HV Introducer Set |
| 00841268103054 | Elite HV Introducer Set |
| 00841268103047 | Elite HV Introducer Set |
| 10841268109480 | Elite HV® F Introducer Kit |