Catalog Number

590851WW

Brand Name

OptraGate Small Refill

Version/Model Number

590851WW

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 09, 2021

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

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

EIF

Product Code Name

ACCESSORIES, RETRACTOR, DENTAL

Public Device Record Key

05143a2e-69cf-46cc-8e3f-f1e40485f828

Public Version Date

April 16, 2021

Public Version Number

1

DI Record Publish Date

April 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-