Catalog Number

-

Brand Name

Evry

Version/Model Number

SYN-0777

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200327,K200327

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Public Device Record Key

eb592cd3-730a-4002-97d9-12b8011dc185

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Package DI Number

10670082000495

Quantity per Package

1

Contains DI Package

00670082000450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-