Catalog Number

-

Brand Name

Spine 32 RS Coil 3T

Version/Model Number

10835689

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170396

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

5a428feb-d6ff-4767-b05d-de03e7fa2a0b

Public Version Date

November 17, 2021

Public Version Number

4

DI Record Publish Date

July 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-