Catalog Number

ESKITI125

Brand Name

EchoStrand Brachytherapy Kit I-125

Version/Model Number

EchoStrand Brachytherapy Kit I-125

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

9a4c99cc-1521-459b-9360-24a0f3c5f594

Public Version Date

August 15, 2019

Public Version Number

3

DI Record Publish Date

October 27, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-