Catalog Number

-

Brand Name

Hitachi

Version/Model Number

Oasis

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LNI

Product Code Name

System, Nuclear Magnetic Resonance Spectroscopic

Public Device Record Key

4b22f346-b225-4139-b1da-08d6df6817c1

Public Version Date

July 14, 2021

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-