Catalog Number

DMC4L-6S

Brand Name

N/AN/A

Version/Model Number

DMC4L-6S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2021

Issuing Agency

In GS1

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

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

fc032227-e846-4b45-a56a-5b87b642244b

Public Version Date

September 29, 2021

Public Version Number

4

DI Record Publish Date

September 06, 2019

Package DI Number

50884908147112

Quantity per Package

10

Contains DI Package

00884908147117

Package Discontinue Date

September 24, 2021

Package Status

Not in Commercial Distribution

Package Type

box