Catalog Number

-

Brand Name

Regard™

Version/Model Number

315749

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K982188,K982188

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

99e4d04b-db45-4d0b-b67e-bc1197bb012f

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 30, 2019

Package DI Number

10326053105743

Quantity per Package

20

Contains DI Package

00326053105746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-