Catalog Number

SKY-200-15

Brand Name

Skytron Acidic Neutralizer

Version/Model Number

SKY-200-15

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MEC

Product Code Name

Disinfector, medical devices

Public Device Record Key

6a4f121e-790e-434d-8e20-7fa674de5d1a

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-