Catalog Number

71816

Brand Name

HydroSil Go™ Intermittent Urinary Catheter

Version/Model Number

71816

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

c83511e2-84aa-4ff8-b0ae-9360ea4e4f07

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 08, 2015

Package DI Number

10801741098038

Quantity per Package

30

Contains DI Package

00801741098031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA