Catalog Number

10.310.1050

Brand Name

Accell Connexus

Version/Model Number

10.310.1050

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"

Yes

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

K060306

Product Code

NUN

Product Code Name

BONE GRAFTING MATERIAL, HUMAN SOURCE

Public Device Record Key

0afa2bae-7c97-480d-8b99-7752b8f0b196

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-