Catalog Number

264221

Brand Name

COE®

Version/Model Number

264221

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

EBH

Product Code Name

MATERIAL, IMPRESSION TRAY, RESIN

Public Device Record Key

fc75f6e9-7e24-4132-b621-09fe2a35e6e5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 10, 2017

Package DI Number

D6582642214

Quantity per Package

50

Contains DI Package

D6582642212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton