Catalog Number

-

Brand Name

Intermittent Catheter

Version/Model Number

4982

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103086,K103086,K103086

Product Code

EZD

Product Code Name

Catheter, Straight

Public Device Record Key

12b79684-2c2d-4a16-af33-8ee1d25b610c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00616784498232

Quantity per Package

12

Contains DI Package

00616784498225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-