SNUC FULLY GUIDED KIT

Basic Information

• Brand Name: SNUC FULLY GUIDED KIT
• Primary DI: 08800020849939
• Version / Model: SFGK
• Company Name: SNUCONE Co.,LTD.
• Labeler DUNS: 688806132
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-20
• Public Version: 1
• Public Version Date: 2023-02-28
• Public Version Status: New
• Public Device Record Key: d845a6fa-e0c1-4229-bb26-e89e6158bafb

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
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	08800020849939	GS1

Customer Contacts

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