Sprint Quattro Secure S®
GUDID 00643169550971
LEAD 6947M97 SPRINT US DF4 MCRD NG ACI
MEDTRONIC, INC.
Endocardial defibrillation lead| Primary Device ID | 00643169550971 |
| NIH Device Record Key | 332333a3-3873-4434-a1eb-edb6226e3895 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sprint Quattro Secure S® |
| Version Model Number | 6947M97 |
| 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 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 | 00643169550971 [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 | 2015-04-14 |
On-Brand Devices [Sprint Quattro Secure S®]
| 00613994808004 | LEAD 6935M49 DF4 ACTIVE SC US EN |
| 00613994718891 | LEAD 6935M97 DF4 ACTIVE SC US EN |
| 00613994718877 | LEAD 6935M72 DF4 ACTIVE SC US EN |
| 00613994718853 | LEAD 6935M62 DF4 ACTIVE SC US EN |
| 00613994718839 | LEAD 6935M55 DF4 ACTIVE SC US EN |
| 00643169550971 | LEAD 6947M97 SPRINT US DF4 MCRD NG ACI |
| 00643169550964 | LEAD 6947M72 SPRINT US DF4 MCRD NG ACI |
| 00643169550957 | LEAD 6947M62 SPRINT US DF4 MCRD NG ACI |
| 00643169550940 | LEAD 6947M55 SPRINT US DF4 MCRD NG ACI |
| 00643169550933 | LEAD 6947M49 SPRINT US DF4 MCRD NG ACI |
| 00643169550926 | LEAD 6935M97 US DF4 NG ACI |
| 00643169550919 | LEAD 6935M72 US DF4 NG ACI |
| 00643169550902 | LEAD 6935M62 US DF4 NG ACI |
| 00643169550896 | LEAD 6935M55 US DF4 NG ACI |
| 00643169550889 | LEAD 6935M49 US DF4 NG ACI |
| 00643169309791 | LEAD 6935M97 USA DF4 EN NG ACI |
| 00643169309784 | LEAD 6935M72 USA DF4 EN NG ACI |
| 00643169309777 | LEAD 6935M62 USA DF4 EN NG ACI |
| 00643169309760 | LEAD 6935M55 USA DF4 EN NG ACI |
| 00643169309753 | LEAD 6935M49 USA DF4 EN NG ACI |
Trademark Results [Sprint Quattro Secure S]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPRINT QUATTRO SECURE S 77336605 3689990 Live/Registered |
Medtronic, Inc. 2007-11-26 |
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