Catalog Number

MC2L-6K

Brand Name

N/AN/A

Version/Model Number

MC2L-6K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 2022

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

7903c7b3-4718-4eee-a386-d0ce8ca60abf

Public Version Date

August 19, 2022

Public Version Number

5

DI Record Publish Date

July 02, 2019

Package DI Number

50884908028114

Quantity per Package

10

Contains DI Package

00884908028119

Package Discontinue Date

August 11, 2022

Package Status

Not in Commercial Distribution

Package Type

box