Elite HV® R Hydrophilic Introducer Kit CLI-228-45
GUDID 10841268109312
Elite HV® R Hydrophilic Introducer Kit
GALT MEDICAL CORP.
Haemostasis valve| Primary Device ID | 10841268109312 |
| NIH Device Record Key | 45173997-515d-455c-b4cc-af5d870dee58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elite HV® R Hydrophilic Introducer Kit |
| Version Model Number | CLI-228-45 |
| Catalog Number | CLI-228-45 |
| 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 |
Customer Support Contacts
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com | |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com |
Device Dimensions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109315 [Primary] |
| GS1 | 10841268109312 [Package] Contains: 00841268109315 Package: Shelf Box [5 Units] In Commercial Distribution |
| GS1 | 20841268109319 [Package] Package: Shipper Box [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043525
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
[10841268109312]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2020-12-11 |
On-Brand Devices [Elite HV® R Hydrophilic Introducer Kit]
| 10841268109442 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109435 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109428 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109411 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109404 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109398 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109381 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109374 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109367 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109350 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109343 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109336 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109329 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109312 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109305 | Elite HV® R Hydrophilic Introducer Kit |
| 10841268109299 | Elite HV® R Hydrophilic Introducer Kit |
Trademark Results [Elite HV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELITE HV 78691289 3120596 Live/Registered |
Galt Medical Corporation 2005-08-12 |
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