Neodent

Basic Information

• Brand Name: Neodent
• Primary DI: 07899878010685
• Version / Model: 127.011
• Catalog Number: 127.011
• Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.
• Labeler DUNS: 906713888
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 2
• Public Version Date: 2023-12-21
• Public Version Status: Update
• Public Device Record Key: f764bb0e-5166-4039-af13-b8d83b7419e0

Device Description

BONE MILL

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
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	07899878010685	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from Sunlight