Catalog Number

3895

Brand Name

Sense Mirror

Version/Model Number

3895

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 11, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FTX

Product Code Name

MIRROR, GENERAL & PLASTIC SURGERY

Public Device Record Key

1cf56f91-2cab-44ec-83d4-091ad90f55e2

Public Version Date

April 13, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-