SPEED Coaxial Archwire

GUDID 75402950390028

Hespeler Orthodontics Limited

Orthodontic archwire

• Primary Device ID: 75402950390028
• NIH Device Record Key: eb81c3ed-a9da-494d-9cb2-31b94fc41d9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Coaxial Archwire
• Version Model Number: 75402950300027
• Company DUNS: 203297635
• Company Name: Hespeler Orthodontics Limited
• Device Count: 10
• 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	75402950300027 [Primary]
GS1	75402950390028 [Unit of Use]

FDA Product Code

• DZC: 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: 2022-11-18
• Device Publish Date: 2022-11-10

On-Brand Devices [SPEED Coaxial Archwire]

• 75402950390028: 75402950300027
• 07540295900058: 07540295000123