Catalog Number

-

Brand Name

Shield System

Version/Model Number

TPL0001

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

-

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

K212159

Product Code

OWB

Product Code Name

Interventional Fluoroscopic X-Ray System

Public Device Record Key

ed9664c6-6f17-4f81-abbb-3535587c1a61

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-