HydroSteer™ 405058
GUDID 15414734054963
Guidewires
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Cardiac/peripheral vascular guidewire, single-use| Primary Device ID | 15414734054963 |
| NIH Device Record Key | d63f7c89-9922-493e-83c6-d3bfb1fc7aef |
| Commercial Distribution Discontinuation | 2018-06-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HydroSteer™ |
| Version Model Number | 405058 |
| Catalog Number | 405058 |
| Company DUNS | 040960379 |
| Company Name | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION |
| 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 | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 Centimeter |
| Outer Diameter | 0.035 Inch |
| Length | 150 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. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734054966 [Primary] |
| GS1 | 15414734054963 [Package] Contains: 05414734054966 Package: [5 Units] Discontinued: 2018-06-29 Not 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 | 4 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [HydroSteer™]
| 15414734055199 | Guidewires |
| 15414734055182 | Guidewires |
| 15414734055175 | Guidewires |
| 15414734055168 | Guidewires |
| 15414734055151 | Guidewires |
| 15414734055144 | Guidewires |
| 15414734055137 | 405075 |
| 15414734055120 | Guidewires |
| 15414734055113 | Guidewires |
| 15414734055106 | Guidewires |
| 15414734055090 | Guidewires |
| 15414734055083 | Guidewires |
| 15414734055076 | 405069 |
| 15414734055069 | 405068 |
| 15414734055052 | 405067 |
| 15414734055045 | Guidewires |
| 15414734055038 | 405065 |
| 15414734055021 | 405064 |
| 15414734055007 | 405062 |
| 15414734054987 | 405060 |
| 15414734054970 | Guidewires |
| 15414734054963 | Guidewires |
| 15414734054949 | 405056 |
| 15414734054932 | Guidewires |
| 15414734054925 | Guidewires |
| 15414734054918 | Guidewires |
| 15414734028506 | 405083 |
| 15414734028490 | 405082 |
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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