geneX® ds

Basic Information

• Brand Name: geneX® ds
• Primary DI: 15060155710959
• Version / Model: 980-002
• Catalog Number: 980-002
• Company Name: BIOCOMPOSITES LTD
• Labeler DUNS: 424382307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-07
• Public Version: 1
• Public Version Date: 2020-01-15
• Public Version Status: New
• Public Device Record Key: e744c387-8009-4426-a6bf-f1386c2e76af

Device Description

geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	888.3045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060155710959	GS1
Previous	50601557109526	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.5cc

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 45 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 39 – 113 Degrees Fahrenheit