Catalog Number

ILG-60F

Brand Name

ImmobiLoc

Version/Model Number

ILG-60F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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,DEN130036

Product Code

PCT

Product Code Name

Prostate Immobilizer Rectal Balloon

Public Device Record Key

e1caeb5f-2c95-451f-b6dc-5511426243ee

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

20851546007039

Quantity per Package

5

Contains DI Package

10851546007032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box