Tornado™ - Bioactive Bone Matrix, 10 cc Moldable Strip - Spine Wave, Inc.

Duns Number:067789763

Device Description: Bioactive Bone Matrix, 10 cc Moldable Strip

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More Product Details

Catalog Number

-

Brand Name

Tornado™

Version/Model Number

11-5800

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

-

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

1f1ac91f-dbdc-4179-aa4e-4de3f2e717f6

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINE WAVE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3264