Catalog Number

20621-295XP

Brand Name

OPUS Silicone Gel Breast Implant

Version/Model Number

20621-295XP

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"

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

P070004

Product Code

FTR

Product Code Name

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Public Device Record Key

fadc393f-edf9-41c1-a08d-df88f0992fdf

Public Version Date

May 23, 2019

Public Version Number

1

DI Record Publish Date

May 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-