SPEED Buccal Tube Samples

GUDID 07540295900027

Hespeler Orthodontics Limited

Orthodontic bracket, metal

• Primary Device ID: 07540295900027
• NIH Device Record Key: 7b98ab35-bb03-4f1a-8cc6-e52e957e5602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Buccal Tube Samples
• Version Model Number: 07540295000079
• Company DUNS: 203297635
• Company Name: Hespeler Orthodontics Limited
• Device Count: 20
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540295000048 [Primary]
GS1	07540295000055 [Primary]
GS1	07540295000062 [Primary]
GS1	07540295000079 [Primary]
GS1	07540295900027 [Unit of Use]
GS1	75402950100108 [Previous]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-19
• Device Publish Date: 2024-08-09

Devices Manufactured by Hespeler Orthodontics Limited

• 07540295900010 - SPEED Bracket: 2024-08-19
• 07540295900027 - SPEED Buccal Tube Samples: 2024-08-19
• 07540295900027 - SPEED Buccal Tube Samples: 2024-08-19
• 07540295900034 - SPEED Convertible Buccal Tube: 2024-08-19
• 07540295900041 - SPEED Beta Titanium Archwire: 2024-08-19
• 07540295900058 - SPEED Coaxial Archwire: 2024-08-19
• 07540295900065 - SPEED D-Wire - Nickel Titanium: 2024-08-19
• 07540295900072 - SPEED D-Wire - Stainless Steel: 2024-08-19
• 07540295900089 - Hills Dual-Geometry Wire: 2024-08-19