GuideRight™ 405022
GUDID 15415067009262
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| Primary Device ID | 15415067009262 |
| NIH Device Record Key | 3fba0b13-37ca-4e3d-9087-70b383f05b99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GuideRight™ |
| Version Model Number | 405022 |
| Catalog Number | 405022 |
| 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 |
Device Dimensions
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 0.97 Millimeter |
| Length | 150 Centimeter |
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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067009265 [Primary] |
| GS1 | 15415067009262 [Package] Contains: 05415067009265 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K935170
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 | 2015-12-02 |
On-Brand Devices [GuideRight™]
Trademark Results [GuideRight]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUIDERIGHT 87852320 not registered Live/Pending |
GuideRight Assessments, LLC 2018-03-27 |
 GUIDERIGHT 77413917 3772274 Dead/Cancelled |
Dreambox Learning Inc. 2008-03-05 |
 GUIDERIGHT 75916824 not registered Dead/Abandoned |
Virtual Carrier Network, Inc. 2000-02-10 |
 GUIDERIGHT 75222634 2181424 Dead/Cancelled |
Daig Corporation 1997-01-08 |
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