Catalog Number

SS9X5CMS

Brand Name

Spacer 5cm Synthetic 5 piece

Version/Model Number

Spacer 5cm Synthetic 5 piece

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

Yes

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

-

FDA Premarket Submission

-

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

d3825484-3a6a-4191-80b8-66ded749e6f0

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

-