Catalog Number

I.02.01.Z800

Brand Name

StecoTitanmagnetics®

Version/Model Number

I.02.01.Z800

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

KCZ

Product Code Name

Prosthesis, Breast, External, Used With Adhesive

Public Device Record Key

cb7e9db5-4bcc-4691-8f4a-05bb51250f3e

Public Version Date

April 15, 2019

Public Version Number

2

DI Record Publish Date

March 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-