Catalog Number

-

Brand Name

Spectros T-Stat

Version/Model Number

CTH-060-SUR 2.5cm

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

b4e14bd0-60d0-4408-b830-6dd41e0ab0ec

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

10851136007008

Quantity per Package

5

Contains DI Package

00851136007001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box