OSTEON - Bone grafting material, synthetic - GENOSS CO., Ltd.

Duns Number:690083006

Device Description: Bone grafting material, synthetic

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More Product Details

Catalog Number

GBG1020 (0.5cc)

Brand Name

OSTEON

Version/Model Number

GBG1020 (0.5cc)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LYC

Product Code Name

Bone grafting material, synthetic

Device Record Status

Public Device Record Key

1fe5583e-3f0d-4b75-bb9f-62bf4ddb503d

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENOSS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 414