Catalog Number

-

Brand Name

7 Fr. Ureteral catheter

Version/Model Number

Ureteral catheter

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

K180354,K180354

Product Code

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

209544db-48c4-4444-8561-41ca3180da20

Public Version Date

April 22, 2020

Public Version Number

4

DI Record Publish Date

February 11, 2019

Package DI Number

20854913006055

Quantity per Package

10

Contains DI Package

10854913006058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box