fortoss® VITAL - fortoss® VITAL is a simple to use, synthetic, - BIOCOMPOSITES LTD

Duns Number:424382307

Device Description: fortoss® VITAL is a simple to use, synthetic, resorbable material containing pure ß Tri-Ca fortoss® VITAL is a simple to use, synthetic, resorbable material containing pure ß Tri-Calcium Phosphate (ß TCP) and Calcium Sulfate. When mixed with the solution the ß TCP/Calcium Sulfate matrix produces a mouldable cohesive paste. ß Tri-Calcium Phosphate act as a scaffold through which new bone grows. The Calcium Sulfate hinders soft tissue ingrowth. Its resorption provides a calcium source early in the regenerative process. The product does not contain any animal tissue

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More Product Details

Catalog Number

BG4-10

Brand Name

fortoss® VITAL

Version/Model Number

BG4-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 02, 2020

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

LYC

Product Code Name

Bone Grafting Material, Synthetic

Device Record Status

Public Device Record Key

1019bd5e-5e3c-427f-9e1c-1c7d7bf1de5d

Public Version Date

November 02, 2020

Public Version Number

3

DI Record Publish Date

May 31, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCOMPOSITES LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 89