Catalog Number

NA

Brand Name

JMA Optic

Version/Model Number

01170011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

bb870253-e0f7-4042-aaae-606bf3c225b9

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-