Catalog Number

R9900099

Brand Name

Ch24 round silicone catheter

Version/Model Number

001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

fde83105-138f-47d1-93c8-7c2c5b447bf1

Public Version Date

June 22, 2022

Public Version Number

3

DI Record Publish Date

April 20, 2020

Package DI Number

M640R99000990012

Quantity per Package

10

Contains DI Package

M640R99000990011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Unit of sale box