Catalog Number

21748-02

Brand Name

Spine Srs

Version/Model Number

1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 10, 2021

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170750

Product Code

MUJ

Product Code Name

System,Planning,Radiation Therapy Treatment

Public Device Record Key

6487aca4-f6c3-4b58-aa35-a86629134cc4

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-