Catalog Number

09-25

Brand Name

Parker Labs

Version/Model Number

Transeptic Cleansing Solution

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 18, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

068bf6f9-ab09-4666-b05b-2fcb30784ea7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-