Catalog Number

316

Brand Name

Dale Foley Catheter Holder

Version/Model Number

316

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYJ

Product Code Name

Holder, Ureteral Catheter

Public Device Record Key

61a26358-d3d0-4a87-897c-2be36a4edfbe

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

H84103162

Quantity per Package

10

Contains DI Package

H84103161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box