Reamer

Basic Information

• Brand Name: Reamer
• Primary DI: 07640156472257
• Version / Model: 3.03.437
• Company Name: Thommen Medical AG
• Labeler DUNS: 481614829
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-13
• Public Version: 1
• Public Version Date: 2020-07-21
• Public Version Status: New
• Public Device Record Key: 7d7fa4ab-aa0c-425d-b34a-e61badd5958f

Device Characteristics

• Single Use: No
• 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: 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63662	Dental implant suprastructure reamer	A manually-operated dental laboratory instrument intended to be used to smooth and refine the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, by means of a rotating abrasive action. It is used to remove minor casting flashes on the mating surface of the suprastructure during the production of a final suprastructure; it is not intended for intraoral use. It is in the form of a metallic cylinder which may be cannulated, and is available in various diameters and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640156472257	GS1