Catalog Number

5571

Brand Name

GUIDELINER

Version/Model Number

IPN922787

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

-

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

6d2321f2-20aa-4fc5-958c-9792d37b94bd

Public Version Date

April 07, 2022

Public Version Number

1

DI Record Publish Date

March 30, 2022

Package DI Number

20841156109124

Quantity per Package

1

Contains DI Package

10841156109127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box