Catalog Number

PROT 50

Brand Name

MEDRAD® PRO-TEKT Endorectal Balloon

Version/Model Number

PROT 50

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"

Yes

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

EXX

Product Code Name

Probe, Rectal, Non-Powered

Public Device Record Key

0adbc13d-f670-4738-8848-a22343cce76b

Public Version Date

March 11, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10616258005703

Quantity per Package

50

Contains DI Package

00616258005706

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-