Molded Products, Inc. - Dual End Cap - Male/Female - MOLDED PRODUCTS, INC.

Duns Number:157506015

Device Description: Dual End Cap - Male/Female

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More Product Details

Catalog Number

MPC-123

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-123

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

5155a972-6cd2-406e-b6e6-805a47eef500

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

Additional Identifiers

Package DI Number

B144MPC1231

Quantity per Package

100

Contains DI Package

B144MPC1230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag

"MOLDED PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 24