Catalog Number

-

Brand Name

Regard™

Version/Model Number

ET0610

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

FTN

Product Code Name

Plastic Surgery And Accessories Kit

Public Device Record Key

b6b69d9f-0103-4c85-8bbc-76d50c4ad9c4

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

May 04, 2018

Package DI Number

20326053110287

Quantity per Package

3

Contains DI Package

10326053110280

Package Discontinue Date

September 24, 2019

Package Status

Not in Commercial Distribution

Package Type

-