Slim Line

Basic Information

• Brand Name: Slim Line
• Primary DI: 08809544905589
• Version / Model: RS263635
• Catalog Number: RS263635
• Company Name: Dentium Co., Ltd.
• Labeler DUNS: 689514395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-14
• Public Version: 1
• Public Version Date: 2020-05-22
• Public Version Status: New
• Public Device Record Key: 7611ac31-f55d-4926-b46d-55c682518e89

Device Description

Chisel, Osteotome, Surgical

Device Characteristics

• Single Use: No
• 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: 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: 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
EMM	CHISEL, OSTEOTOME, SURGICAL	Dental	872.4565	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	08809544905589	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.6	Millimeter
Length	35	Millimeter