TL-HEX TRUELOK HEXAPOD SYSTEM

Basic Information

• Brand Name: TL-HEX TRUELOK HEXAPOD SYSTEM
• Primary DI: 18053800895924
• Version / Model: 1
• Catalog Number: 50-20020
• Company Name: ORTHOFIX SRL
• Labeler DUNS: 438793622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-01
• Public Version: 1
• Public Version Date: 2021-06-09
• Public Version Status: New
• Public Device Record Key: b9c736f2-d3e5-4243-94b8-ebb81b9e1dd3

Device Description

TL-HEX KIT ID FRAME PEDIATRIC

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILT	Adaptor, Recreational	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61577	Skin marking sticker	A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18053800895924	GS1

Customer Contacts

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