Catalog Number

382-50

Brand Name

HUDSON RCI

Version/Model Number

IPN044281

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K850335,K850335

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

c4fb10ce-8706-47aa-9fa8-780ddf2094be

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

24026704582062

Quantity per Package

48

Contains DI Package

04026704582068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box