Catalog Number

8207-00-00

Brand Name

NBX

Version/Model Number

8207-00-00

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

JEC

Product Code Name

COMPONENT, TRACTION, INVASIVE

Public Device Record Key

a406a595-eede-4833-b396-a9b85edc71cf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-