Catalog Number

100114842

Brand Name

SUPSTANCE Small

Version/Model Number

100114842

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

-

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

2286ab9a-5219-4398-931f-1c1bed25fba5

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

November 12, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-