Catalog Number

-

Brand Name

Mon-a-Therm

Version/Model Number

90053

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

-

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

-

FDA Premarket Submission

K831567,K831567,K831567

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

24adc181-2a60-425a-ac02-6a03b18c12e6

Public Version Date

February 08, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521078062

Quantity per Package

2

Contains DI Package

20884521078069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE