Catalog Number

VC1810

Brand Name

TEMNO Elite™

Version/Model Number

00884450398098

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

2e2d5c32-08c4-4c09-aeef-c525f33c0e47

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

Package DI Number

10884450398095

Quantity per Package

5

Contains DI Package

00884450398098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-