Bone Shark®

Basic Information

• Brand Name: Bone Shark®
• Primary DI: 00850048404090
• Version / Model: BS-101
• Catalog Number: BS-101
• Company Name: Tarca LLC
• Labeler DUNS: 079211808
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-20
• Public Version: 1
• Public Version Date: 2022-12-28
• Public Version Status: New
• Public Device Record Key: 6313ea5a-b104-4699-b819-cbd84c84dd0c

Device Description

Bone Shark® Sterile Disposable Bone Mill

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYS	Bone Mill	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61086	Powered bone mill cartridge	A sterile cutting device intended to be powered by a bone mill motor 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. It typically consists of a cutting disc, a plunger, and collection drawer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850048404090	GS1
Package	00850048404106	GS1	Case	8	In Commercial Distribution