Catalog Number

T1415/B

Brand Name

TEMNO®

Version/Model Number

10884450444419

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

d1f21ec8-4151-49f5-8e62-b9cd08f6153b

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

April 06, 2021

Package DI Number

20884450444416

Quantity per Package

18

Contains DI Package

10884450444419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-