Agili-C

GUDID 07290019087182

5X Agili-C D7.5 Implant

CARTIHEAL (2009) LTD

Osteochondral matrix implant

• Primary Device ID: 07290019087182
• NIH Device Record Key: 21b718e7-dab1-4417-b8c3-2b2c39e04d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agili-C
• Version Model Number: CHP0755
• Company DUNS: 533214388
• Company Name: CARTIHEAL (2009) 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com
• Phone: +97298810400
• Email: info@cartiheal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019087182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210034

FDA Product Code

• QRU: Implant, Resorbable, For Articular Osteochondral Repair

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [Agili-C]

• 07290019087038: Agili-C Implant Diameter 15mm , Length 10mm
• 07290019087021: Agili-C Implant Diameter 12.5mm, Length 10mm
• 07290019087014: Agili-C Implant Diameter 10mm, Length 10mm
• 07290019087007: Agili-C Implant Diameter 7.5mm Length 10mm
• 07290019087182: 5X Agili-C D7.5 Implant
• 07290019087175: 3X Agili-C D7.5 Implant Pack
• 07290019087168: 2X Agili-C D7.5 Implant Pack