Catalog Number

-

Brand Name

ORTHOSOURCE

Version/Model Number

873-131-T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JEX

Product Code Name

Plier, Orthodontic

Public Device Record Key

555075d4-66e1-48fc-ae5f-a2f17907256c

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-