devemed

Basic Information

• Brand Name: devemed
• Primary DI: 04061644010677
• Version / Model: 2550-3
• Company Name: devemed GmbH
• Labeler DUNS: 506826739
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 1
• Public Version Date: 2020-04-23
• Public Version Status: New
• Public Device Record Key: 847c1cd0-072e-4cdc-b97d-6ddd6cc2bffa

Device Description

Bone mill Ø 16 mm with relacable Titanium cutting surfaces for preparation of autogenous bone

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: 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
LYS	Bone Mill	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18129	Manual bone mill	A manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04061644010677	GS1

Customer Contacts

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