Catalog Number

ISO-100

Brand Name

IsoLoc

Version/Model Number

ISO-100

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

b88c2eb9-9f20-4cfb-b2ed-001e311b45dd

Public Version Date

July 27, 2018

Public Version Number

4

DI Record Publish Date

January 31, 2018

Package DI Number

20851546007107

Quantity per Package

5

Contains DI Package

10851546007100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box