Catalog Number

M1024244

Brand Name

N/A

Version/Model Number

M1024244

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

-

Product Code

EYC

Product Code Name

CATHETER, UPPER URINARY TRACT

Public Device Record Key

7ef14f28-a94d-4694-b0ee-07e7e290cc65

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2016

Package DI Number

70885403251650

Quantity per Package

25

Contains DI Package

10885403251658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack