OCS-B Collagen

Basic Information

• Brand Name: OCS-B Collagen
• Primary DI: 08809186549493
• Version / Model: CB-0110-005
• Company Name: Nibec Co., Ltd.
• Labeler DUNS: 687796909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 359ee84e-0df5-4998-bd7b-146a5f4cb8ff

Device Description

OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation.

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: Yes
• 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	08809186549493	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142040	000

Device Sizes

Type	Value	Unit	Text
Weight	.05	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius