AccessGUDID - DEVICE: fortoss® VITAL (50601557102282)

GUDID

Device Identifier (DI) Information

Brand Name: fortoss® VITAL
Version or Model: BG4-10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BG4-10
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 50601557102282
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone Grafting Material, Synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1cc

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