ENDOBON®

Basic Information

• Brand Name: ENDOBON®
• Primary DI: 03599870097588
• Version / Model: ROXLG80
• Company Name: BIOMET 3I, LLC
• Labeler DUNS: 186127825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2015-09-10
• Public Version: 3
• Public Version Date: 2022-03-10
• Public Version Status: Update
• Public Device Record Key: 3bca8f30-ba95-48ff-a472-66e86bf89783

Device Description

ENDOBON® XENOGRAFT GRANULES LARGE PARTICLE 8.0ML

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone grafting material, synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48097	Bone matrix implant, animal-derived, non-bioabsorbable	A sterile non-bioabsorbable device made primarily of animal-derived bone matrix (e.g., heat-treated hydroxyapatite ceramic from animal cancellous bone) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowths of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, cylinders, or granules.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03599870097588	GS1
Unit of Use	33599870097589	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Particle Size 1 mm
Total Volume	1	Milliliter
Device Size Text, specify			Particle Size 2 mm