Duns Number:315620229
Catalog Number
106119
Brand Name
Si-2
Version/Model Number
106119
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P980023,P980023
Product Code
DTB
Product Code Name
permanent pacemaker Electrode
Public Device Record Key
f7fa6bea-ddbc-4676-8c90-a59e875ffe6a
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
August 25, 2014
Package DI Number
04035479000455
Quantity per Package
5
Contains DI Package
04035479145262
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 97 |
| 3 | A medical device with high risk that requires premarket approval | 402 |