Catalog Number

-

Brand Name

Duo System Stereo

Version/Model Number

271991

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"

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

62a78dbd-133b-48a3-8c14-780d9315d0ce

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

04250195611390

Quantity per Package

10

Contains DI Package

04250195611383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-