Catalog Number

-

Brand Name

Tuflex Premium

Version/Model Number

271651

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

MIJ

Product Code Name

Needle, Tumor Localization

Public Device Record Key

c9e1a971-fc75-4b33-80e2-f5fee83abfd3

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 31, 2020

Package DI Number

04250195611666

Quantity per Package

10

Contains DI Package

04250195611659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-