Catalog Number

CUS12

Brand Name

CUSTOMED

Version/Model Number

152570148312

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

-

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

284075f4-73a8-48ad-9a68-8e5f82df2e72

Public Version Date

April 20, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M208CUS121

Quantity per Package

100

Contains DI Package

M208CUS120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

100/BOX