SPEED Intra-Oral Reference Tool

GUDID 07540295000451

Hespeler Orthodontics Limited

Orthodontic appliance dimension gauge

• Primary Device ID: 07540295000451
• NIH Device Record Key: 2a33d034-927d-4b03-b37d-c45f21d35136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEED Intra-Oral Reference Tool
• Version Model Number: 07540295000451
• Company DUNS: 203297635
• Company Name: Hespeler Orthodontics Limited
• Device Count: 1
• 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: false
• Lot Batch: false
• 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	07540295000451 [Primary]
GS1	75402951100015 [Previous]

FDA Product Code

• DZN: Instruments, Dental Hand

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 Intra-Oral Reference Tool]

• 75402951100015: 75402951100015
• 07540295000451: 07540295000451