Catalog Number

-

Brand Name

Anti-Glutamate receptor (type NMDA) IFA

Version/Model Number

FA 112d-2010-51

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 24, 2020

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

K100017

Product Code

OSK

Product Code Name

Anti-Glutamate Receptor (Type Nmda) Ifa

Public Device Record Key

6baaedd3-a698-4ce8-ac67-eef5d676fca9

Public Version Date

July 16, 2020

Public Version Number

4

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-