Sprint Quattro Secure MRI™ SureScan™
GUDID 00643169356610
LEAD 6947M55 QUATTRO SECURE MRI US
MEDTRONIC, INC.
Endocardial defibrillation lead| Primary Device ID | 00643169356610 |
| NIH Device Record Key | be488330-31d6-4c9f-87d1-0c916ec90c75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sprint Quattro Secure MRI™ SureScan™ |
| Version Model Number | 6947M55 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Device Dimensions
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
| Length | 55 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169356610 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P920015
FDA Product Code
| DTB | permanent pacemaker Electrode |
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 | 2018-08-13 |
| Device Publish Date | 2015-09-21 |
On-Brand Devices [Sprint Quattro Secure MRI™ SureScan™]
| 00643169692381 | LEAD 694765 SPRINT QUATTRO US MRI |
| 00643169692374 | LEAD 694758 SPRINT QUATTRO US MRI |
| 00643169356627 | LEAD 6947M62 QUATTRO SECURE MRI US |
| 00643169356610 | LEAD 6947M55 QUATTRO SECURE MRI US |
| 00763000180324 | LEAD 6947M62 MRI US DF4 RCMCRD |
| 00763000180317 | LEAD 6947M55 MRI US DF4 RCMCRD |
| 00763000180263 | LEAD 694765 SPRINT US MRI RCMCRD |
| 00763000180256 | LEAD 694758 SPRINT US MRI RCMCRD |
Trademark Results [Sprint Quattro Secure MRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPRINT QUATTRO SECURE MRI 85959232 4867469 Live/Registered |
Medtronic, Inc. 2013-06-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.