FDA.reportPublic FDA data

Agili-C Mini Disposable Toolset

Primary DI
07290019087045
Brand
Agili-C Mini Disposable Toolset
Company
CARTIHEAL (2009) LTD
Model
MINI-DS
Catalog number
MINI-DS
Device description
Agili-C Mini Disposable Toolset
Published
2022-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBOInstruments Designed For Press-Fit Osteochondral Implants

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBOInstruments Designed For Press-Fit Osteochondral ImplantsOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019087045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019087045072900190870457290019087045

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972098810400info@cartiheal.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019087199Agili-C Surgical Toolset Full Sterilization TrayRU-TRAY-F2023-12-01
07290019087168Agili-CCHP07522023-05-31
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
10810128461495CARTIHEAL AGILI-C Disposable Toolset 7.5T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461501CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461518CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
00840124520493FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2025-05-16
00840124514195PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124514201FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124512825PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512832PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512849PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512856PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512863PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124513853FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00840124513884FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00860010346907Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346914Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346921Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346938Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE Swami Medical, LLCQBO2024-08-22
07290019087199Agili-C Surgical Toolset Full Sterilization TrayCARTIHEAL (2009) LTDQBO2023-12-01
07290019087052Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087069Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087076Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087083Agili-C Sterilization CaseCARTIHEAL (2009) LTDQBO2022-10-04
07290019087090Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087106Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087113Agili-C Quick Connect Handle CARTIHEAL (2009) LTDQBO2022-10-04
07290019087120Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087137Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087144Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087151Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
10603295490531C-STEMDEPUY (IRELAND)QBO2022-09-22