SPEED Opening Instrument

GUDID 07540295000444

Hespeler Orthodontics Limited

Self-ligating orthodontic bracket open/close tool

• Primary Device ID: 07540295000444
• NIH Device Record Key: 5f2103da-d1a9-414a-8f5f-78d25165e1d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Opening Instrument
• Version Model Number: 07540295000444
• 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: 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	07540295000444 [Primary]
GS1	75402951000018 [Previous]

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: 2024-08-19
• Device Publish Date: 2024-08-09

On-Brand Devices [SPEED Opening Instrument]

• 75402951000018: 75402951000018
• 07540295000444: 07540295000444