Catalog Number

3310-00-01

Brand Name

CTM-400

Version/Model Number

3310-00-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

IXO

Product Code Name

Synchronizer, Ecg/Respirator, Radiographic

Public Device Record Key

31c6e524-0aa0-4587-8de1-7439607e2ac7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-