Catalog Number

UC3.5

Brand Name

NEOMED*

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

d9537fa9-254c-4630-afba-025098bca440

Public Version Date

August 12, 2021

Public Version Number

1

DI Record Publish Date

August 04, 2021

Package DI Number

10350770003181

Quantity per Package

10

Contains DI Package

00350770003184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS