Wizard CaP - Calcium Bone Void Filler (3 cc) - Vivorte, Inc

Duns Number:078400984

Device Description: Calcium Bone Void Filler (3 cc)

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More Product Details

Catalog Number

-

Brand Name

Wizard CaP

Version/Model Number

3 cc

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2021

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

37fd4a5a-629a-4f83-9814-e9669cd56d62

Public Version Date

August 06, 2021

Public Version Number

1

DI Record Publish Date

July 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VIVORTE, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12