Catalog Number

44-010-01

Brand Name

KONG-TL VBR System, Holding Sleeve

Version/Model Number

44-010-01

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

-

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

94c735c6-bf2a-413d-a677-7b6a7e6050f8

Public Version Date

January 18, 2022

Public Version Number

2

DI Record Publish Date

June 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-