OsteoGen Plugs - Slim, 6x25mm

Basic Information

• Brand Name: OsteoGen Plugs - Slim, 6x25mm
• Primary DI: 00855286006051
• Version / Model: OPS625
• Company Name: Impladent, Ltd.
• Labeler DUNS: 199838400
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-27
• Public Version: 4
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: dc8adddf-6ec8-4363-a91d-18cf1a9a4f93

Device Description

OsteoGen Plugs. OsteoGen bone graft combined with a bovine achilles tendon carrier.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
46543	Composite bone graft	An implantable device that combines various bone substitute materials and/or bone growth factors to serve as a structural bone replacement typically when bone is lost due to trauma or osteoporosis. It is available in a variety of combinations such as collagen/ceramic, or polytetrafluoroethylene (PTFE) with carbon fibres.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00855286006068	GS1		5	In Commercial Distribution
Primary	00855286006051	GS1
Package	00855286006419	GS1		10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K090794	000