SPRINT QUATTRO SECURE® DXAC/DSP
GUDID 00643169535947
LEAD 694765 SPRINT QUATTRO US SI MCRD
MEDTRONIC, INC.
Endocardial defibrillation lead| Primary Device ID | 00643169535947 |
| NIH Device Record Key | e4a83912-3cee-4603-9642-ebd02640bc35 |
| Commercial Distribution Discontinuation | 2018-11-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SPRINT QUATTRO SECURE® DXAC/DSP |
| Version Model Number | 694765 |
| 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 | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 Centimeter |
| Length | 65 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 | 00643169535947 [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 | 4 |
| Public Version Date | 2018-12-13 |
| Device Publish Date | 2014-11-26 |
On-Brand Devices [SPRINT QUATTRO SECURE® DXAC/DSP]
| 00613994740939 | LEAD 694775 SPRINT US 75CM FPA QUAD |
| 00613994740922 | LEAD 694765 SPRINT US 65CM FPA QUAD |
| 00613994740915 | LEAD 694758 SPRINT US 58CM FPA QUAD |
| 00613994740908 | LEAD 6947100 SPRINT US 100CM FPA QUAD |
| 00643169535978 | LEAD 6947100 SPRINT QUATTRO US SI MCRD |
| 00643169535961 | LEAD 694758 SPRINT QUATTRO US SI MCRD |
| 00643169535954 | LEAD 694775 SPRINT QUATTRO US SI MCRD |
| 00643169535947 | LEAD 694765 SPRINT QUATTRO US SI MCRD |
Trademark Results [SPRINT QUATTRO SECURE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPRINT QUATTRO SECURE 78030444 2820385 Live/Registered |
MEDTRONIC, INC. 2000-10-13 |
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