Catalog Number

-

Brand Name

Imager II

Version/Model Number

M0064004040

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

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

d98e9735-343b-4afc-a60b-4b9b359b0d9a

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

08714729430339

Quantity per Package

5

Contains DI Package

08714729751991

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-