Catalog Number

CCH2220

Brand Name

Temno

Version/Model Number

CCH2220

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 05, 2023

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

-

Product Code

GDF

Product Code Name

GUIDE, NEEDLE, SURGICAL

Public Device Record Key

af8ac145-d008-4b58-86ba-8944f145c00b

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2017

Package DI Number

50885403088764

Quantity per Package

5

Contains DI Package

10885403088766

Package Discontinue Date

March 05, 2023

Package Status

In Commercial Distribution

Package Type

Case