Catalog Number

TE2006

Brand Name

TEMNO Elite™

Version/Model Number

00884450397893

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

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

910ff733-be35-4243-98ea-47f0146e3ba8

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 02, 2022

Package DI Number

20884450397897

Quantity per Package

4

Contains DI Package

10884450397890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-