SPEED Protector Coil

GUDID 07540295000314

Hespeler Orthodontics Limited

Orthodontic archwire protection sleeve

• Primary Device ID: 07540295000314
• NIH Device Record Key: b946500e-d120-4edf-a668-b376797460de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Protector Coil
• Version Model Number: 07540295000314
• Company DUNS: 203297635
• Company Name: Hespeler Orthodontics Limited
• Device Count: 1
• 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	07540295000314 [Primary]
GS1	75402950600011 [Previous]

FDA Product Code

• DZD: Tube, 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 Protector Coil]

• 75402950600011: 75402950600011
• 07540295000314: 07540295000314