Duns Number:890719636
Device Description: Replacement Stimulus Generator Unit for EPS320 Family of Cardiac Stimulator Reconfigurable Replacement Stimulus Generator Unit for EPS320 Family of Cardiac Stimulator Reconfigurable systems of EPS320B, StimCor, StimLab and ORLab
Catalog Number
MP3008
Brand Name
Micropace
Version/Model Number
MP3008
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
-
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
-
Product Code
JOQ
Product Code Name
Generator, Pulse, Pacemaker, External Programmable
Public Device Record Key
2e4b743b-3608-4441-8b16-1998e63d354f
Public Version Date
January 13, 2021
Public Version Number
4
DI Record Publish Date
July 01, 2016
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. | 4 |