Catalog Number

-

Brand Name

GSO GS1 Spacer

Version/Model Number

502312

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

df87acc4-ac0b-46b9-ba04-29f7947a711a

Public Version Date

January 14, 2022

Public Version Number

4

DI Record Publish Date

August 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-