Catalog Number

-

Brand Name

GEM 21S®

Version/Model Number

LBGEM05

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P040013,P040013,P040013,P040013,P040013,P040013

Product Code

NPZ

Product Code Name

Bone Grafting Material, Dental, With Biologic Component

Public Device Record Key

457b7521-fbca-448d-b068-74c0a7031f94

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-