SPEED Reinforcing Tube

Basic Information

• Brand Name: SPEED Reinforcing Tube
• Primary DI: 75402950600028
• Version / Model: 75402950600028
• Company Name: Hespeler Orthodontics Limited
• Labeler DUNS: 203297635
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 1
• Public Version Date: 2022-11-18
• Public Version Status: New
• Public Device Record Key: 9755f9bc-cb3b-46ab-87a7-8ad92d68745b

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZD	Tube, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65562	Orthodontic archwire protection sleeve	A small, hollow tube/cylinder intended to be cut to a selected length and placed around an orthodontic archwire to protect the archwire from damage and to protect teeth, gums, and cheeks from archwire exposure during orthodontic treatment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	75402950690029	GS1
Primary	75402950600028	GS1