Catalog Number

3232-050U

Brand Name

SIENTRA Oval Carving Block Implant

Version/Model Number

3232-050U

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 13, 2022

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"

-

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

K981851

Product Code

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

79992e4e-928c-43a4-9e98-05f55bb157d2

Public Version Date

June 13, 2022

Public Version Number

4

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-