SPEED Intra-Oral Reference Tool

GUDID 75402951100015

Hespeler Orthodontics Limited

Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge Orthodontic appliance dimension gauge

• Primary Device ID: 75402951100015
• NIH Device Record Key: 7187f073-15f5-428c-9ee2-9a45f9157abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Intra-Oral Reference Tool
• Version Model Number: 75402951100015
• Company DUNS: 203297635
• Company Name: Hespeler Orthodontics Limited
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	75402951100015 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2022-11-18
• Device Publish Date: 2022-11-10

Devices Manufactured by Hespeler Orthodontics Limited

• 75402950490117 - SPEED Split Stop: 2023-06-22
• 75402950090027 - SPEED Bracket: 2023-03-21
• 75402950090034 - SPEED Bracket: 2023-03-21
• 75402950190116 - SPEED Single Buccal Tube: 2023-03-21
• 75402950190123 - SPEED Single Buccal Tube: 2023-03-21
• 75402950190130 - SPEED Double Buccal Tube: 2023-03-21
• 75402950190147 - SPEED PE Mini Buccal Tube: 2023-03-21
• 75402950190154 - SPEED Double Buccal Tube: 2023-03-21