Catalog Number

FPRMC00036

Brand Name

Positioning System

Version/Model Number

FPRMC00036

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082919

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

12f5eab5-60e4-4e9a-92c0-569cfbc853e5

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

November 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-