Catalog Number

KE 19005105

Brand Name

BioResorb® Macro Pore

Version/Model Number

KE 19005105

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

K050260

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

76b052c3-95df-4673-99c7-bafeada87661

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-