Catalog Number

ISO-60

Brand Name

IsoLoc

Version/Model Number

ISO-60

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2018

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

DEN130036,DEN130036

Product Code

PCT

Product Code Name

Prostate Immobilizer Rectal Balloon

Public Device Record Key

6c503fc6-240b-47ca-9cec-23f971c05628

Public Version Date

January 28, 2020

Public Version Number

5

DI Record Publish Date

January 31, 2018

Package DI Number

30851546007098

Quantity per Package

20

Contains DI Package

20851546007091

Package Discontinue Date

January 31, 2018

Package Status

Not in Commercial Distribution

Package Type

Shelf Package