TRIGEN MAX IM REAMER HEAD 15 MM, FRONT CUTTING

Basic Information

• Brand Name: TRIGEN MAX IM REAMER HEAD 15 MM, FRONT CUTTING
• Primary DI: 07640187918038
• Version / Model: T18770
• Catalog Number: T18770
• Company Name: MPS Micro Precision Systems AG
• Labeler DUNS: 482204059
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-22
• Public Version: 1
• Public Version Date: 2025-01-30
• Public Version Status: New
• Public Device Record Key: 5db7aaa1-4056-4bc5-b10b-fd8ce4a58605

Device Description

Intramedullary reamer head is used in combination with the Intramedullary reamer shaft to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTO	Reamer	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35297	Medullary canal orthopaedic reamer, flexible	An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylindrical device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640187918038	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]