Catalog Number

-

Brand Name

Tuflex Premium

Version/Model Number

271652

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 16, 2022

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

99320194-02ea-4bb2-b789-f98c30044b6d

Public Version Date

August 17, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2020

Package DI Number

04250195611680

Quantity per Package

10

Contains DI Package

04250195611673

Package Discontinue Date

August 16, 2022

Package Status

Not in Commercial Distribution

Package Type

-