Duns Number:101835833
Catalog Number
LV-1 PLUG
Brand Name
LV-1 Plug
Version/Model Number
667147-300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 03, 2020
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
K024156
Product Code
DTD
Product Code Name
pacemaker lead Adaptor
Public Device Record Key
16c68287-cee3-467b-bf03-dda965ebee24
Public Version Date
March 19, 2021
Public Version Number
6
DI Record Publish Date
November 21, 2017
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 |