Catalog Number

50816G

Brand Name

Magic3 Go Male Coude Catheter with SureGrip

Version/Model Number

50816G

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

3772da8a-30a6-4dce-a632-198b086d6447

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Package DI Number

20801741137031

Quantity per Package

360

Contains DI Package

10801741137034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX