SPEED Opening Instrument

GUDID 75402951000018

Hespeler Orthodontics Limited

Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool

• Primary Device ID: 75402951000018
• NIH Device Record Key: b16a57b7-e04e-4ab5-93de-254fe0261f14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Opening Instrument
• Version Model Number: 75402951000018
• 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	75402951000018 [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