Catalog Number

C-PPDY-700-022394-IMH

Brand Name

Fuhrman

Version/Model Number

G55722

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)

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

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

18be21e0-40b4-40a3-a74a-76781a0a4c8e

Public Version Date

October 12, 2020

Public Version Number

1

DI Record Publish Date

October 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-