K2M VENADO HA/TCP Cancellous Granules - VENADO Granules Bone Graft System is a sterile - BERKELEY ADVANCED BIOMATERIALS, LLC

Duns Number:081067703

Device Description: VENADO Granules Bone Graft System is a sterile bone graft comprised of Bi-Ostetic (60% hyd

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More Product Details

Catalog Number

4815-T0525

Brand Name

K2M VENADO HA/TCP Cancellous Granules

Version/Model Number

4815-T0525

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

K023703

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

96b1b122-648b-4972-a814-64a3881e8855

Public Version Date

June 19, 2020

Public Version Number

6

DI Record Publish Date

April 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BERKELEY ADVANCED BIOMATERIALS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 178