Catalog Number

1023864

Brand Name

Safco Kleer Mirrors

Version/Model Number

1023864

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KAI

Product Code Name

MIRROR, ENT

Public Device Record Key

e0d3ffdb-1eb2-4f38-a0d3-bdced7bc62bf

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-