Catalog Number

102-9800

Brand Name

Superion IDS Kit

Version/Model Number

102-9800

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

NQO

Product Code Name

Prosthesis, Spinous Process Spacer/Plate

Public Device Record Key

215e534e-c863-4ef7-a44c-9e9d2f8af9fd

Public Version Date

August 05, 2021

Public Version Number

5

DI Record Publish Date

April 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-