Catalog Number

C11-078

Brand Name

GUIDOR

Version/Model Number

easy-graft CLASSIC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2021

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

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

K131385,K131385

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

31a4c3de-3d7a-441f-8416-0bd997b8326f

Public Version Date

August 30, 2021

Public Version Number

4

DI Record Publish Date

October 22, 2015

Package DI Number

17640164360130

Quantity per Package

3

Contains DI Package

07640164360096

Package Discontinue Date

May 03, 2021

Package Status

Not in Commercial Distribution

Package Type

Box