Catalog Number

TT2020/B

Brand Name

TEMNO Evolution®

Version/Model Number

10884450443634

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

FCG

Product Code Name

Biopsy needle

Public Device Record Key

97059b38-eb33-4ec6-bd3f-a8972bb9ee1b

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

January 04, 2021

Package DI Number

20884450443631

Quantity per Package

12

Contains DI Package

10884450443634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-