Catalog Number

MPC-181

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-181

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

83eb2d58-4c48-4b64-9def-73380fbabe52

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Package DI Number

B144MPC1813

Quantity per Package

12

Contains DI Package

B144MPC1811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case