FASSIER-DUVAL TELESCOPIC IM SYSTEM

Basic Information

• Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
• Primary DI: 07540194006929
• Version / Model: MC200-TUBE 56
• Catalog Number: MC200-TUBE 56
• Company Name: Pega Medical Inc
• Labeler DUNS: 257315713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-07
• Public Version: 2
• Public Version Date: 2020-08-11
• Public Version Status: Update
• Public Device Record Key: 91a4622e-9033-493f-bafe-46adbab74e34

Device Description

CUTTER TUBE ASSEMBLY Ø5.6mm

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
HXZ	CUTTER, WIRE	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44805	Orthopaedic implantable-device cutter	A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540194006929	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	3.55	Millimeter

Storage Conditions

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