Bone Mill Plus

Basic Information

• Brand Name: Bone Mill Plus
• Primary DI: 07613327542134
• Version / Model: 5420100000
• Catalog Number: 5420-100-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-22
• Public Version: 1
• Public Version Date: 2022-12-30
• Public Version Status: New
• Public Device Record Key: c2837137-d293-446e-a194-7c9aa2a74149

Device Description

Base

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61085	Powered bone mill motor	A non-sterile motorized base unit intended to be used with a disposable cutting cartridge to create particles of bone autografts (i.e., bone harvested from and transplanted into the same patient) for implantation during a bone regeneration or bone grafting procedure. The motor is intended to provide the rotational force required by the cutters in the cartridge to produce the bone particles; it is typically powered by a line-powered surgical power tool control unit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327542134	GS1