Duns Number:006261481
Device Description: LEAD 6947M62 SPRINT US DF4 MCRD NG ACI
Catalog Number
-
Brand Name
Sprint Quattro Secure S®
Version/Model Number
6947M62
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P920015
Product Code
DTB
Product Code Name
permanent pacemaker Electrode
Public Device Record Key
338a6bfd-8bca-4c54-8c75-74ab53d78068
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
April 14, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |