HydroSteer™ 408011
GUDID 15414734028322
Guidewires
ST. JUDE MEDICAL, INC.
Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use| Primary Device ID | 15414734028322 |
| NIH Device Record Key | 2a98f47d-f536-4704-8b2e-b6d4a17c9cc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HydroSteer™ |
| Version Model Number | 408011 |
| Catalog Number | 408011 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 260 Centimeter |
| Outer Diameter | 0.035 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark, dry place. Keep away from sunlight and keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734028325 [Primary] |
| GS1 | 15414734028322 [Package] Contains: 05414734028325 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K000011
FDA Product Code
| DQX | WIRE, GUIDE, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-16 |
On-Brand Devices [HydroSteer™]
| 15414734055205 | Torque Device |
| 15414734055014 | Guidewires |
| 15414734054994 | Guidewires |
| 15414734054956 | Guidewires |
| 15414734028322 | Guidewires |
Trademark Results [HydroSteer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDROSTEER 97257011 not registered Live/Pending |
Super ATV, LLC 2022-02-08 |
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