Catalog Number

CCB5-S-55

Brand Name

ContourFlex™ Gluteal Implant, Smooth (Round)

Version/Model Number

Size: 13.5cm x 13.5cm x 4.5cm

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

K982688

Product Code

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

17be4927-627c-4d63-9cea-7dd7f7b9eb53

Public Version Date

April 07, 2021

Public Version Number

1

DI Record Publish Date

March 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-