Chisel handle

Basic Information

• Brand Name: Chisel handle
• Primary DI: 07640187910513
• Version / Model: T14584
• Catalog Number: T14584
• 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: 2020-08-25
• Public Version: 2
• Public Version Date: 2022-11-18
• Public Version Status: Update
• Public Device Record Key: 045c9c38-2299-425d-9c35-b94b833d79b1

Device Description

A hand-held instrument used to maintain and hold chisel blade of different designs (straight, curved, offset, etc.). The exchange of the chisel blades occur simply by tightening and loosening the screw by use of the Allen key. In case the chisel blade remains stocked, the slap hammer can be screwed at the handle extremity. 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
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62895	Orthopaedic osteotome handle	A hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds this part of the instrument and manually imparts a force to it using a surgical mallet or hammer; it is made of metal and/or polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640187910513	GS1

Customer Contacts

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