Catalog Number

119888

Brand Name

Encompass 7 Channel Top MRI Head Coil - 1.5T

Version/Model Number

01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K190668

Product Code

HBL

Product Code Name

Holder, Head, Neurosurgical (Skull Clamp)

Public Device Record Key

9b7d3a56-2f4c-4f73-b514-da6ff5a8daba

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

November 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-