MClass

Basic Information

• Brand Name: MClass
• Primary DI: 10845854039151
• Version / Model: TN250-100-90
• Catalog Number: TN250-100-90
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-10-13
• Public Version: 1
• Public Version Date: 2021-10-21
• Public Version Status: New
• Public Device Record Key: e22ffefc-2bb5-4899-ac8f-4ec5f17284ac

Device Description

MClass Oscillating Saw Blade 25mm x 1.00mm (0.039”) x 90mm

Device Characteristics

• Single Use: Yes
• 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: 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: 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
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46476	Surgical saw blade, oscillating, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20845854039158	GS1	Box	1	In Commercial Distribution
Primary	10845854039151	GS1
Unit of Use	00845854039154	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY