Duns Number:006261481
Device Description: LEAD 419588 DEPLOYABLE 88CM EN, US
Catalog Number
-
Brand Name
ATTAIN STARFIX®
Version/Model Number
419588
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2019
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
P060039,P060039
Product Code
DTB
Product Code Name
permanent pacemaker Electrode
Public Device Record Key
28038d7d-d0a3-4fb7-a864-0ebd0f9fa87b
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
September 23, 2014
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 |