Catalog Number

MSR450

Brand Name

Single Use Mammary Sizer

Version/Model Number

MSR450

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MRD

Product Code Name

Sizer, Mammary, Breast Implant Volume

Public Device Record Key

85f4ae80-6d38-41b7-887a-aee97b7a291a

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

May 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-