SPEED Single Buccal Tube

GUDID 75402950190116

Hespeler Orthodontics Limited

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal

• Primary Device ID: 75402950190116
• NIH Device Record Key: ac28c307-94f9-4c2e-99be-5f954dfef075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Single Buccal Tube
• Version Model Number: 75402950100115
• 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	75402950100115 [Primary]
GS1	75402950190116 [Unit of Use]

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: 2023-03-21
• Device Publish Date: 2023-03-13

On-Brand Devices [SPEED Single Buccal Tube]

• 75402950190017: 75402950100016
• 75402950190123: 75402950100122
• 75402950190116: 75402950100115