Catalog Number

R9900099

Brand Name

Ch24 round silicone catheter

Version/Model Number

000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 03, 2020

Issuing Agency

In HIBCC

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

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

064729b2-9ac3-4a96-8546-59c4e0d2432b

Public Version Date

June 22, 2022

Public Version Number

5

DI Record Publish Date

January 27, 2017

Package DI Number

M640R99000990002

Quantity per Package

10

Contains DI Package

M640R99000990001

Package Discontinue Date

February 03, 2020

Package Status

Not in Commercial Distribution

Package Type

White box