Duns Number:101835833
Catalog Number
-
Brand Name
IS4/DF4 PLUG
Version/Model Number
IS4/DF4 PLUG
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
K143463
Product Code
DTD
Product Code Name
Pacemaker Lead Adaptor
Public Device Record Key
6c12a691-c7e7-4b2f-9830-8ae6863f4ebf
Public Version Date
March 19, 2021
Public Version Number
5
DI Record Publish Date
October 16, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 592 |
3 | A medical device with high risk that requires premarket approval | 16 |