Catalog Number

854-208

Brand Name

Clear Rotation Wedges

Version/Model Number

854-208

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2021

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

Yes

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

ECI

Product Code Name

BAND, ELASTIC, ORTHODONTIC

Public Device Record Key

679a47d5-3495-498c-a293-d168ed907939

Public Version Date

September 22, 2021

Public Version Number

2

DI Record Publish Date

September 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-