Catalog Number

MPC-110

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-110

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"

Yes

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

K925927,K925927,K925927

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

e9a1fabc-6af8-4495-96f1-26d2c308a766

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 04, 2018

Package DI Number

B144MPC1101

Quantity per Package

100

Contains DI Package

B144MPC1100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-