Catalog Number

ACT1820

Brand Name

TEMNO

Version/Model Number

ACT1820

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

265219fe-c923-4f9b-8aa2-84568c2c210c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 09, 2017

Package DI Number

50885403110670

Quantity per Package

5

Contains DI Package

10885403110672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case