Catalog Number

MPC-124-B

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-124-B

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)

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,K925927

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

11a0ca02-2b60-4c04-b6e6-2529080de7f4

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

September 08, 2016

Package DI Number

B144MPC124B3

Quantity per Package

25

Contains DI Package

B144MPC124B2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case