Catalog Number

TEVC2010

Brand Name

TEMNO Elite™

Version/Model Number

00884450397756

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

f78d4edd-9e9d-4a3c-88a8-d5a7046e95ee

Public Version Date

January 31, 2022

Public Version Number

1

DI Record Publish Date

January 21, 2022

Package DI Number

20884450397750

Quantity per Package

4

Contains DI Package

10884450397753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-