Catalog Number

53514GS

Brand Name

Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male

Version/Model Number

53514GS

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OHR

Product Code Name

Catheter care tray

Public Device Record Key

61c24b9f-7685-439c-97b9-6e927a8a9070

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

Package DI Number

10801741072700

Quantity per Package

50

Contains DI Package

00801741072703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA