Catalog Number

-

Brand Name

IntraMarX 3D

Version/Model Number

Combo

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

K201106,K201106

Product Code

FFX

Product Code Name

System, Gastrointestinal Motility (Electrical)

Public Device Record Key

2789d80d-0996-433c-808d-a5cef929eb0f

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Package DI Number

00850015518256

Quantity per Package

10

Contains DI Package

00850015518232

Package Discontinue Date

December 08, 2020

Package Status

Not in Commercial Distribution

Package Type

box