Micropace - Replacement Stimulus Generator Unit for EPS320 - MICROPACE PTY LIMITED

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

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More Product Details

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

Product Characteristics

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 Details

Product Code

JOQ

Product Code Name

Generator, Pulse, Pacemaker, External Programmable

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROPACE PTY LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4