Sprint Quattro®
GUDID 00643169335592
LEAD 6946M97 USA EN SPRINT DF4 PASSIVE
MEDTRONIC, INC.
Endocardial defibrillation lead| Primary Device ID | 00643169335592 |
| NIH Device Record Key | dbc59507-844c-41c2-a851-cdc4903b20ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sprint Quattro® |
| Version Model Number | 6946M97 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | 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 | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
| Length | 97 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169335592 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P920015
FDA Product Code
| LWS | Implantable cardioverter defibrillator (non-CRT) |
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 | 2016-08-07 |
On-Brand Devices [Sprint Quattro®]
| 00613994249975 | LEAD 6944-65 US FPA QUAD DSP SOLN |
| 00613994249951 | LEAD 6944-58 US FPA QUAD DSP SOLN |
| 00643169451476 | LEAD 6944-100 SPRINT QUATTRO US |
| 00643169451469 | LEAD 6944-65 SPRINT QUATTRO US |
| 00643169451452 | LEAD 6944-75 SPRINT QUATTRO US |
| 00643169440852 | LEAD 6944-58 SPRINT QUATTRO US |
| 00643169335592 | LEAD 6946M97 USA EN SPRINT DF4 PASSIVE |
| 00643169335585 | LEAD 6946M72 USA EN SPRINT DF4 PASSIVE |
| 00643169335578 | LEAD 6946M62 USA EN SPRINT DF4 PASSIVE |
| 00643169335561 | LEAD 6946M55 USA EN SPRINT DF4 PASSIVE |
Trademark Results [Sprint Quattro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPRINT QUATTRO 75758564 2635937 Live/Registered |
Medtronic, Inc. 1999-07-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.