Carbon offset reamer handle Harris with parking

Basic Information

• Brand Name: Carbon offset reamer handle Harris with parking
• Primary DI: 07640187916867
• Version / Model: T18381
• Catalog Number: T18381
• 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: 2020-08-17
• Public Version: 2
• Public Version Date: 2022-11-18
• Public Version Status: Update
• Public Device Record Key: ebaf2fae-d83a-49b5-9c38-d33bf1e10082

Device Description

Offset Reamer handles designed for required minimally invasive surgical approach of the hip joint. Various connections with reamer cutting tool and couplings with power tool (Big AO, Stryker-Zimmer/Hall and Harris) are available. It could be disassembled in 5 parts allowing the cleaning of the instrument. This is a reusable device.

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47845	Surgical power tool adaptor	A connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640187916867	GS1

Customer Contacts

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