Catalog Number

1632-04

Brand Name

Peracidin™

Version/Model Number

Gallon

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

K962959,K962959

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Public Device Record Key

1011268f-6962-4670-a8c2-854ee971ef3b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 29, 2016

Package DI Number

00898021000228

Quantity per Package

4

Contains DI Package

00898021000198

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case