Catalog Number

500118200

Brand Name

Prostate Stabilization Set

Version/Model Number

500118200

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

IWJ

Product Code Name

System, Applicator, Radionuclide, Manual

Public Device Record Key

44a1478f-a2fa-44f5-9e0f-02ad1b5145d8

Public Version Date

July 19, 2022

Public Version Number

1

DI Record Publish Date

July 11, 2022

Package DI Number

20886333004397

Quantity per Package

10

Contains DI Package

00886333004393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box