Catalog Number

GBG1020 (2.0cc)

Brand Name

OSTEON

Version/Model Number

GBG1020 (2.0cc)

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

K102015

Product Code

LYC

Product Code Name

Bone grafting material, synthetic

Public Device Record Key

079ebe77-8d6c-4d4f-bb75-6a7a56d8a4af

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-