Catalog Number

UC3.5

Brand Name

NeoMed Urinary Drainage Catheter

Version/Model Number

UC3.5

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

c7973c9b-9f12-4467-a4c1-c4ea9734807f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

20817584010905

Quantity per Package

16

Contains DI Package

10817584010908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper