Agili-C

Primary DI
07290019087021
Brand
Agili-C
Company
CARTIHEAL (2009) LTD
Model
CH-125
Device description
Agili-C Implant Diameter 12.5mm, Length 10mm
Published
2022-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

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
07290019087021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019087021072900190870217290019087021

GMDN Terms#

Term, Definition table
TermDefinition
Osteochondral void filling materialA bioabsorbable, implantable device designed 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 associated with the implantation may be packaged with the implant.

Regulatory Flags#

DUNS number
533214388
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019087168Agili-CCHP07522023-05-31
07290019087175Agili-CCHP07532023-05-31
07290019087182Agili-CCHP07552023-05-31
07290019087007Agili-CCH-0752022-10-04
07290019087014Agili-CCH-1002022-10-04
07290019087038Agili-CCH-1502022-10-04
07290019087045Agili-C Mini Disposable ToolsetMINI-DSMINI-DS2022-10-04
07290019087199Agili-C Surgical Toolset Full Sterilization TrayRU-TRAY-F2023-12-01
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
07290019087168Agili-CCARTIHEAL (2009) LTDQRU2023-05-31
07290019087175Agili-CCARTIHEAL (2009) LTDQRU2023-05-31
07290019087182Agili-CCARTIHEAL (2009) LTDQRU2023-05-31
07290019087007Agili-CCARTIHEAL (2009) LTDQRU2022-10-04
07290019087014Agili-CCARTIHEAL (2009) LTDQRU2022-10-04
07290019087038Agili-CCARTIHEAL (2009) LTDQRU2022-10-04