Catalog Number

11868152190

Brand Name

Ethyl Alcohol ETH

Version/Model Number

11868152190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2018

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

K952839

Product Code

DML

Product Code Name

NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD

Public Device Record Key

d0681570-7154-4b27-b35f-8512f37e9610

Public Version Date

November 03, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-