Mighty-Tuff™

GUDID 00810042124479

Bracket Tie Organizer - Prefilled 6400 Ties

ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

Orthodontic archwire/bracket ligature

• Primary Device ID: 00810042124479
• NIH Device Record Key: d250df0e-64f0-4ff9-aae9-f708ebea8e74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mighty-Tuff™
• Version Model Number: MTOR-520
• Company DUNS: 077801124
• Company Name: ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 6 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810042124479 [Primary]

FDA Product Code

• ECI: Band, Elastic, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-22
• Device Publish Date: 2020-08-12

Devices Manufactured by ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

• 00810042124745 - OSE: 2023-08-21 EXPANDO RETRACTOR - SMALL #1
• 00810042124752 - OSE: 2023-08-21 EXPANDO RETRACTOR - MEDIUM #2
• 00810042124769 - OSE: 2023-08-21 EXPANDO RETRACTOR - LARGE #3
• 00810042124738 - OSE: 2023-07-28 PALATAL FIXED EXPANDER - 12MM
• 00810042124547 - OSE: 2023-06-29 SCANDEE LIP & CHEEK RETRACTOR - MED/CLEAR
• 00810042124554 - OSE: 2023-06-29 SCANDEE LIP & CHEEK RETRACTOR - MED/BLUE
• 00810042124561 - OSE: 2023-06-29 SCANDEE LIP & CHEEK RETRACTOR - MED/WHITE
• 00810042124578 - OSE: 2023-06-29 SCANDEE LIP & CHEEK RETRACTOR - MED/RED