Catalog Number

RMD-002-006

Brand Name

mcompass Extension Tube Set

Version/Model Number

RMD-002-006

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

K143031,K143031,K143031

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

196d1cc3-c80d-4a74-93be-78677455db14

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

June 25, 2019

Package DI Number

20851607003185

Quantity per Package

5

Contains DI Package

10851607003188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper