Catalog Number

-

Brand Name

Mediplus

Version/Model Number

5765

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

K132890,K132890

Product Code

KOB

Product Code Name

CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Public Device Record Key

73914482-77d4-4adc-afcc-d229185c4a19

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

October 17, 2015

Package DI Number

15055140701609

Quantity per Package

10

Contains DI Package

05055140701602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton