Catalog Number

50600-02

Brand Name

EpiGuide® Bioresorbable Barrier Matrix

Version/Model Number

50600-02

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)

Yes

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

K940643

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

8af1275e-65f4-4d42-a9a5-59933e543b61

Public Version Date

February 13, 2019

Public Version Number

4

DI Record Publish Date

September 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-