Catalog Number

FRA1820

Brand Name

Temno

Version/Model Number

FRA1820

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2021

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

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

0858f9da-738b-4b58-90d3-7d83e08859bc

Public Version Date

February 26, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2017

Package DI Number

50885403089464

Quantity per Package

10

Contains DI Package

10885403089466

Package Discontinue Date

February 26, 2021

Package Status

Not in Commercial Distribution

Package Type

Case