Catalog Number

-

Brand Name

Stellar Medical

Version/Model Number

L1053SM

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092041

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

e2583767-56ac-47d4-af2b-ab9e6e6cc31e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-