Catalog Number

PP2015/B

Brand Name

TEMNO®

Version/Model Number

10884450443214

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)

-

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

ed77326b-efc1-405e-ab82-4357259bbc60

Public Version Date

February 20, 2020

Public Version Number

1

DI Record Publish Date

February 12, 2020

Package DI Number

20884450443211

Quantity per Package

18

Contains DI Package

10884450443214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-