Catalog Number

09-0057

Brand Name

N/A

Version/Model Number

09-0057

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

EIF

Product Code Name

ACCESSORIES, RETRACTOR, DENTAL

Public Device Record Key

c1d7bf9c-c6fb-4876-bcc4-46624ae51ccd

Public Version Date

October 05, 2018

Public Version Number

2

DI Record Publish Date

August 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-