SMALL DIAMETER IMPLANT SURGICAL KIT

Basic Information

• Brand Name: SMALL DIAMETER IMPLANT SURGICAL KIT
• Primary DI: D785SDISURGICALKIT0
• Version / Model: SMALL DIAMETER IMPLANT SURGICAL KIT
• Catalog Number: SDI SURGICAL KIT
• Company Name: OCO BIOMEDICAL INC
• Labeler DUNS: 094146123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-12
• Public Version: 1
• Public Version Date: 2024-03-20
• Public Version Status: New
• Public Device Record Key: 42b8c634-d582-40fc-8620-01b810db690f

Device Description

SMALL DIAMETER IMPLANT SURGICAL KIT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJL	Bur, Dental	Dental	872.3240	1
DZA	Drill, Dental, Intraoral	Dental	872.4130	1
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D785SDISURGICALKIT0	HIBCC