SPEED Supercable Kit

Basic Information

• Brand Name: SPEED Supercable Kit
• Primary DI: 07540295000345
• Version / Model: 07540295000345
• Company Name: Hespeler Orthodontics Limited
• Labeler DUNS: 203297635
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-09
• Public Version: 1
• Public Version Date: 2024-08-19
• Public Version Status: New
• Public Device Record Key: e3e29251-1fdc-48af-8b7a-7463bbec593a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
31799	Orthodontic appliance dimension gauge	A dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device.	No	Active
33209	Orthodontic pliers	A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.	No	Active
38741	Orthodontic lock	A dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	No	Active
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active
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
Primary	07540295000345	GS1
Previous	75402950800015	GS1