Catalog Number

SVRT-7133

Brand Name

SecureVac™ Immobilization System

Version/Model Number

SVRT-7133

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K040773

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

c5747d2b-7b35-45a9-b2ca-3d27fc3c9add

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-