Catalog Number

-

Brand Name

Universal Sterilization Box

Version/Model Number

GM11010340

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160021

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

48d3ef0a-6a50-4fa1-8832-a3ce305e05d5

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

September 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-