Catalog Number

71818

Brand Name

HydroSil Go™ Intermittent Urinary Catheter

Version/Model Number

71818

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

EZD

Product Code Name

CATHETER, STRAIGHT

Public Device Record Key

ddf6c4b4-16f3-4e2b-8e88-70f48708b060

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 08, 2015

Package DI Number

10801741098052

Quantity per Package

30

Contains DI Package

00801741098055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA