Catalog Number

TT1611

Brand Name

TEMNO EVOLUTION

Version/Model Number

TT1611

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)

Yes

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

4b8aed85-4e5c-48b9-90f7-cdad93d5bd7c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Package DI Number

50885403110687

Quantity per Package

5

Contains DI Package

10885403110689

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case