Catalog Number

75156

Brand Name

SPOROX II

Version/Model Number

SPOROX II Sterilizing and Disinfecting Solution

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2016

Issuing Agency

In HIBCC

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

-

Product Code

MED

Product Code Name

Sterilant, medical devices

Public Device Record Key

7fc99140-4277-43d5-9025-a84d09f053f6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-