Elite HV® R Hydrophilic Introducer Kit CLI-228-45
GUDID 10841268109312
Elite HV® R Hydrophilic Introducer Kit
GALT MEDICAL CORP.
Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve Haemostasis valve 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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