SPEED Bracket

GUDID 07540295900010

Hespeler Orthodontics Limited

Orthodontic bracket, metal

• Primary Device ID: 07540295900010
• NIH Device Record Key: bc58188c-131a-45e6-a91d-27408774e9ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Bracket
• Version Model Number: 07540295000031
• Company DUNS: 203297635
• Company Name: Hespeler Orthodontics Limited
• Device Count: 100
• 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	07540295000017 [Primary]
GS1	07540295000024 [Primary]
GS1	07540295000031 [Primary]
GS1	07540295900010 [Unit of Use]
GS1	75402950000019 [Previous]
GS1	75402950000026 [Previous]
GS1	75402950000033 [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

On-Brand Devices [SPEED Bracket]

• 75402950090010: 75402950000019
• 75402950090034: 75402950000033
• 75402950090027: 75402950000026
• 07540295900010: 07540295000031