Genex Bone Graft Substitute 910-005Z

GUDID 15060155711482

genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldable cohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set in situ or placed in the bead mould mat provided to form beads for implantation. When injected the mixture sets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substitute is supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex. genex® Bone Graft Substitute is MR safe.

BIOCOMPOSITES LTD

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• Primary Device ID: 15060155711482
• NIH Device Record Key: 10fcfa41-0594-4293-a912-e7a6351e319c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genex Bone Graft Substitute
• Version Model Number: 910-005Z
• Catalog Number: 910-005Z
• Company DUNS: 424382307
• Company Name: BIOCOMPOSITES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com
• Phone: +4401782338580
• Email: info@biocomposites.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060155711482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212721

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

[15060155711482]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-25
• Device Publish Date: 2022-02-17

On-Brand Devices [Genex Bone Graft Substitute]

• 15060155711499: genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promo
• 15060155711482: genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promo
• 15060155711475: genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promo