Catalog Number

CHKHP-01/B

Brand Name

SCOUT CHECK®

Version/Model Number

00884450434468

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

-

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

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

a4e1e74e-5c56-4eba-bc4e-68bbbd1e602a

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2021

Package DI Number

10884450434465

Quantity per Package

1

Contains DI Package

00884450434468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-