Catalog Number

NA

Brand Name

JMA Optic Schütz

Version/Model Number

01170020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 17, 2021

Issuing Agency

In HIBCC

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

NFS

Product Code Name

Device, Jaw Tracking, For Monitoring Jaw Positions

Public Device Record Key

9df35221-1fac-4fda-b357-8496b88473c2

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

August 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-