Catalog Number

-

Brand Name

Regard

Version/Model Number

NU00263Q

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OJG

Product Code Name

Neurological Tray

Public Device Record Key

fae97274-0f80-462e-885e-b1d81a715b98

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

20194717115387

Quantity per Package

1

Contains DI Package

10194717115380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-