Catalog Number

-

Brand Name

Spectros T-Stat

Version/Model Number

CTH-060-END 2.3M

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

K081233,K081233

Product Code

MUD

Product Code Name

Oximeter, Tissue Saturation

Public Device Record Key

7c5d2bf4-7936-4ae2-b309-7465061c673d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2016

Package DI Number

10851136007022

Quantity per Package

5

Contains DI Package

00851136007025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box