Catalog Number

2010

Brand Name

SentioMMG

Version/Model Number

2010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 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

-

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

-

Product Code

PDQ

Product Code Name

Neurosurgical Nerve Locator

Public Device Record Key

8edf8926-8ca4-4834-bf06-0ade15c1bbdb

Public Version Date

June 26, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-