Catalog Number

Q50-100-X

Brand Name

Q50X

Version/Model Number

Q50-100-X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K120381

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

db169985-070d-4b99-8699-965e715fbd12

Public Version Date

October 11, 2021

Public Version Number

3

DI Record Publish Date

January 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-