REGENEROSS®

Basic Information

• Brand Name: REGENEROSS®
• Primary DI: 00844868035497
• Version / Model: ROAP05
• Company Name: BIOMET 3I, LLC
• Labeler DUNS: 186127825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 3
• Public Version Date: 2022-03-10
• Public Version Status: Update
• Public Device Record Key: d16f3c3f-6a61-4437-8aeb-0fc9ae8aecf7

Device Description

DEMINERALIZED BONE MATRIX (DMB) 0.5CC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
NUN	BONE GRAFTING MATERIAL, HUMAN SOURCE	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47970	Dental bone matrix implant, human-derived	A sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to augment/reconstruct maxillofacial and/or mandibular bone by filling bone voids or gaps caused by trauma or dental surgery. It is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is typically available in the form of a sterile powder, crushed granules, putty, chips, or gel injected with syringe.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844868035497	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Volume 0.5 mL