Catalog Number

NB0715

Brand Name

Particulate 15.0cc

Version/Model Number

NB0715

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

K052494

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

b460f3e9-14ab-451f-85a0-80a92d6ec9a9

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

March 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-