Catalog Number

-

Brand Name

Regard™

Version/Model Number

PL0126

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2020

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

00aae3c4-d191-43bc-989e-2764619e1323

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

May 04, 2018

Package DI Number

20326053101223

Quantity per Package

2

Contains DI Package

10326053101226

Package Discontinue Date

August 26, 2020

Package Status

Not in Commercial Distribution

Package Type

-