Catalog Number

MPC-135

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-135

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K925927,K925927,K925927

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

2efff7df-edcb-4bd8-b066-30c2e60443ba

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 04, 2019

Package DI Number

B144MPC1353

Quantity per Package

40

Contains DI Package

B144MPC1351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case