Catalog Number

-

Brand Name

QLRAD

Version/Model Number

105.1014

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180478,K180478,K180478,K180478,K180478

Product Code

PCT

Product Code Name

Prostate immobilizer rectal balloon

Public Device Record Key

dc5c9081-4c3b-414d-8af0-4ca45ff4b225

Public Version Date

May 26, 2021

Public Version Number

6

DI Record Publish Date

September 28, 2020

Package DI Number

08719326258218

Quantity per Package

100

Contains DI Package

08719326258201

Package Discontinue Date

February 24, 2021

Package Status

Not in Commercial Distribution

Package Type

box