FASSIER-DUVAL TELESCOPIC IM SYSTEM

Basic Information

• Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
• Primary DI: 07540194006738
• Version / Model: FC-DISC
• Catalog Number: FC-DISC
• Company Name: Pega Medical Inc
• Labeler DUNS: 257315713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-06
• Public Version: 2
• Public Version Date: 2020-07-28
• Public Version Status: Update
• Public Device Record Key: 0cf90d13-1e61-46ff-a175-125218a78390

Device Description

DIAMOND DISC

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: 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
HSO	SAW	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64295	Metal-cutting bur	A rotary cutting device consisting of a shaft and a cutting working end made of hard materials (e.g., high-grade steel, carbide, diamond) which is designed to fit into an appropriate powered handpiece that provides the rotation, and is intended for cutting hard metal, typically a device/implant during orthopaedic surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540194006738	GS1

Customer Contacts

• Phone: [phone] ext. 242
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep at room temperature