DirectOss™

Basic Information

• Brand Name: DirectOss™
• Primary DI: 10841307122579
• Version / Model: DXCA251025S
• Catalog Number: DXCA251025S
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Labeler DUNS: 868856969
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ae4dadfc-4e44-44ed-8079-3471c0b51e00

Device Description

Anorganic Bovine Cancellous Bone (250-1000µm) - 0.25cc Syringed

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
NPM	Bone Grafting Material, Animal Source	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47968	Dental bone matrix implant, animal-derived	A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841307122579	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151209	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			250-1000µm, 0.25cc Syringed

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature (15°C/59°F to 25°C/77°F)