Catalog Number

C11-078

Brand Name

GUIDOR easy-graft CLASSIC

Version/Model Number

C11-078

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

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

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

6a5f14c7-3987-4603-ac84-3fbeb4cb7f92

Public Version Date

May 10, 2022

Public Version Number

1

DI Record Publish Date

May 02, 2022

Package DI Number

17640164363193

Quantity per Package

3

Contains DI Package

07640164361819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-