Catalog Number

440

Brand Name

IDEAL IMPLANT

Version/Model Number

44001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P120011

Product Code

FWM

Product Code Name

Prosthesis, Breast, Inflatable, Internal, Saline

Public Device Record Key

0324b5c7-7fb7-400c-a519-e83398d5016c

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-