Catalog Number

300-614

Brand Name

SMALL LIP RETRACTOR *O

Version/Model Number

300-614

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

EIF

Product Code Name

Accessories, Retractor, Dental

Public Device Record Key

2eeca429-598e-4c46-ac3b-c9038cd25772

Public Version Date

February 02, 2021

Public Version Number

4

DI Record Publish Date

May 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-