Agili-C

Primary DI
07290019087168
Brand
Agili-C
Company
CARTIHEAL (2009) LTD
Model
CHP0752
Device description
2X Agili-C D7.5 Implant Pack
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRUImplant, Resorbable, For Articular Osteochondral Repair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRUImplant, Resorbable, For Articular Osteochondral RepairUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210034000Agili-CSmith and Nephew, Inc.2022-03-29QRU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019087168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019087168072900190871687290019087168

GMDN Terms#

Term, Definition table
TermDefinition
Osteochondral matrix implantA sterile bioabsorbable device designed to be implanted to fill osteochondral defects. It is a porous and multilayered device, one layer of synthetic bone substitute material (e.g. ceramics such as tricalcium phosphate or hydroxyapatite) combined with a biological material (e.g., bovine collagen) intended to provide an osteoconductive bone tissue scaffold, and a second layer of predominantly biological material (e.g., bovine collagen) intended to provide a matrix structure that promotes the ingrowth of autologous cells for cartilage regeneration. Instruments to prepare the defect site and insert the implant may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97298810400info@cartiheal.com

Regulatory Flags#

DUNS number
533214388
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019087045Agili-C Mini Disposable ToolsetMINI-DSMINI-DS2022-10-04
07290019087199Agili-C Surgical Toolset Full Sterilization TrayRU-TRAY-F2023-12-01
07290019087175Agili-CCHP07532023-05-31
07290019087182Agili-CCHP07552023-05-31
07290019087007Agili-CCH-0752022-10-04
07290019087014Agili-CCH-1002022-10-04
07290019087021Agili-CCH-1252022-10-04
07290019087038Agili-CCH-1502022-10-04
07290019087052Agili-C Mini Disposable ToolsetMINI-DS-1002022-10-04
07290019087069Agili-C Mini Disposable ToolsetMINI-DS-1252022-10-04
07290019087076Agili-C Mini Disposable ToolsetMINI-DS-1502022-10-04
07290019087083Agili-C Sterilization CaseRU-TRAY2022-10-04
07290019087090Agili-C Cartilage Cutter RU-CC2022-10-04
07290019087106Agili-C Cartilage Cutter RU-CC-1502022-10-04
07290019087113Agili-C Quick Connect Handle RU-QCH2022-10-04
07290019087120Agili-C ToolsetRU-0752022-10-04
07290019087137Agili-C ToolsetRU-1002022-10-04
07290019087144Agili-C ToolsetRU-1252022-10-04
07290019087151Agili-C ToolsetRU-1502022-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019087175Agili-CCARTIHEAL (2009) LTDQRU2023-05-31
07290019087182Agili-CCARTIHEAL (2009) LTDQRU2023-05-31
07290019087007Agili-CCARTIHEAL (2009) LTDQRU2022-10-04
07290019087014Agili-CCARTIHEAL (2009) LTDQRU2022-10-04
07290019087021Agili-CCARTIHEAL (2009) LTDQRU2022-10-04
07290019087038Agili-CCARTIHEAL (2009) LTDQRU2022-10-04