Catalog Number

TT2011/B

Brand Name

TEMNO Evolution®

Version/Model Number

10884450443610

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

871bc68f-ff96-4b77-b5e8-efec48bc3906

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

March 30, 2021

Package DI Number

20884450443617

Quantity per Package

12

Contains DI Package

10884450443610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-