SPEED Split Stop

GUDID 75402950490117

Hespeler Orthodontics Limited

Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock

• Primary Device ID: 75402950490117
• NIH Device Record Key: a600cfdb-de7c-46ff-a08d-1879d330454b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Split Stop
• Version Model Number: 75402950400116
• Company DUNS: 203297635
• Company Name: Hespeler Orthodontics Limited
• Device Count: 50
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	75402950400116 [Primary]
GS1	75402950490117 [Unit of Use]

FDA Product Code

• ECN: Clamp, Wire, 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: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [SPEED Split Stop]

• 75402950490032: 75402950400031
• 75402950490117: 75402950400116