FDA.reportPublic FDA data

CARTIHEAL AGILI-C Disposable Toolset 10

Primary DI
10810128461518
Brand
CARTIHEAL AGILI-C Disposable Toolset 10
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
CHDT-125
Catalog number
340125sn
Published
2025-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10810128461518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081012846151810810128461518

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534123013
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mm0234-109-105145105st2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mm234-113-050124050st2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mm234-113-055124055st2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mm234-113-060124060st2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mm234-113-065124065st2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mm234-113-070124070st2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mm234-113-075124075st2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mm234-113-080124080st2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mm234-113-085124085st2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mm234-113-090124090st2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mm234-113-095124095st2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mm234-113-100124100st2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mm234-113-105124105st2026-08-03
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mm124110st234-113-1102026-08-03
10810128464052VersiTomic 2-Fluted Cannulated Reamer Ø12.0mm234-113-120124120st2026-08-03
10810128464069VersiTomic 2-Fluted Cannulated Reamer Ø13.0mm234-113-130124130st2026-08-03
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmAR-6593-57Q159o570ar2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmAR-6593-59Q159o590ar2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmAR-6593-77Q159o770ar2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmAR-6593-97Q159o970ar2026-07-21

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
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
07290019087045Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
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