Agili-C

GUDID 07290019087014

Agili-C Implant Diameter 10mm, Length 10mm

CARTIHEAL (2009) LTD

Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant Osteochondral matrix implant

• Primary Device ID: 07290019087014
• NIH Device Record Key: 5d2de1c9-2092-4976-a198-2e060ea066da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agili-C
• Version Model Number: CH-100
• 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: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com
• Phone: +972098810400
• Email: info@cartiheal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019087014 [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: 2022-10-12
• Device Publish Date: 2022-10-04

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