Catalog Number

901308

Brand Name

18 French Pediatric Flexi Tip

Version/Model Number

901308

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"

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

FGD

Product Code Name

Catheter, Retention, Barium Enema With Bag

Public Device Record Key

5d4b7d47-c889-4e27-bf29-14de0fde4653

Public Version Date

June 30, 2020

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

30815112021062

Quantity per Package

24

Contains DI Package

10815112021068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box