Catalog Number

-

Brand Name

Flecta Disposable Mirrors

Version/Model Number

SFLEC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EAX

Product Code Name

Mirror, Mouth

Public Device Record Key

6083a3f6-c7bd-480d-92c6-c2a2d1632c80

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-