Catalog Number

-

Brand Name

Regard™

Version/Model Number

70412ROI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

-

Product Code

GAB

Product Code Name

Needle, Suturing, Disposable

Public Device Record Key

bff2b56b-4882-4baa-9fde-4238b8e10c7a

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2020

Package DI Number

20326053102671

Quantity per Package

8

Contains DI Package

30326053102678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-