Catalog Number

ONSM16

Brand Name

O'Neil Intermittent Urinary Catheter

Version/Model Number

16 Gauge

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

-

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

369ccd9a-8e15-4d6f-bc4a-62cc85346cc5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 17, 2017

Package DI Number

09350902001232

Quantity per Package

200

Contains DI Package

09350902001225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton