| Primary Device ID | 10841268108353 |
| NIH Device Record Key | 499bd192-27a9-402f-aed7-c3d0d6eabd12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quiktork Guidewire Torque Device |
| Version Model Number | TOR-100-10 |
| Catalog Number | TOR-100-10 |
| 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 | true |
| 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 | |
| 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 |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Guidewire Diameter | 0.01 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268108356 [Primary] |
| GS1 | 10841268108353 [Package] Contains: 00841268108356 Package: Shelf [10 Units] In Commercial Distribution |
| GS1 | 20841268108350 [Package] Package: Shipper [40 Units] In Commercial Distribution |
| DQX | Wire, Guide, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
[10841268108353]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 10841268108360 | Quiktork Guidewire Torque Device |
| 10841268108353 | Quiktork Guidewire Torque Device |