Catalog Number

SX320T

Brand Name

SSE

Version/Model Number

SX320T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2015

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

MNI

Product Code Name

ORTHOSIS, SPINAL PEDICLE FIXATION

Public Device Record Key

5afdd76c-0df9-4ed4-b010-d09f1a6d809e

Public Version Date

January 15, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-