Catalog Number

SZC-380

Brand Name

Motiva Implant Matrix

Version/Model Number

SZC-380

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

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

bca9f3b0-cf9b-4dc3-b1c5-7a5043c72ce7

Public Version Date

November 02, 2021

Public Version Number

1

DI Record Publish Date

October 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-