Catalog Number

-

Brand Name

Mon-a-Therm

Version/Model Number

90051

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

45871431-e49a-4b0a-827b-4ad87b78a204

Public Version Date

February 01, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884521078021

Quantity per Package

10

Contains DI Package

30884521078028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK