Catalog Number

2296-100-026

Brand Name

NA

Version/Model Number

2296100026

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJL

Product Code Name

BUR, DENTAL

Public Device Record Key

0c4c8564-d2e1-4f89-aa05-2edb6b695c9d

Public Version Date

September 09, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-