FASSIER-DUVAL TELESCOPIC IM SYSTEM

Basic Information

• Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
• Primary DI: 07540194007155
• Version / Model: PRO164
• Catalog Number: PRO164
• Company Name: Orthopediatrics Canada ULC
• Labeler DUNS: 243298854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-06
• Public Version: 8
• Public Version Date: 2025-05-13
• Public Version Status: Update
• Public Device Record Key: 95c3a169-c978-42a2-ac8d-b80928a86a32

Device Description

PROBE Ø6.4mm

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
HTJ	GAUGE, DEPTH	Orthopedic	888.4300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47901	Bone nail trial, reusable	A copy of a final orthopaedic bone nail designed to be introduced into the bone (e.g., proximal and/or distal end of the intramedullary canal of a long bone) to function as a reference for the subsequent introduction of the final bone nail, and typically also guide wire and/or bone screws. It is typically used in conjunction with appropriate holders/positioning devices (not included). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540194007155	GS1

Customer Contacts

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

Storage Conditions

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