Catalog Number

600975-003

Brand Name

MENTOR Diaphragm Valve Fill Tube with 45 Degree Connector

Version/Model Number

600975-003

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

P990075

Product Code

FWM

Product Code Name

Prosthesis, breast, inflatable, internal, saline

Public Device Record Key

791cf032-2bc3-4254-a1e0-c6fdb7ecece5

Public Version Date

February 11, 2021

Public Version Number

5

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-