Catalog Number

HNRT-3501

Brand Name

TruGuard™

Version/Model Number

HNRT-3501

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

K153270,K153270

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

5ce3aa61-11f0-45e8-906a-a9fb2fbc60c4

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-