GUDID 00817573024155

MODULE SAFETY 450g GLOW 10/PK

LANCER ORTHODONTICS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00817573024155
• NIH Device Record Key: 0ec93036-b300-4e08-9e00-ba2d940ada41
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 830-603RM
• Company DUNS: 045545589
• Company Name: LANCER ORTHODONTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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	00817573024155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901958

FDA Product Code

• DZB: Headgear, Extraoral, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-15

Devices Manufactured by LANCER ORTHODONTICS, INC.

• 00817573020003 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CEN +12T +5A 018 UL
• 00817573020010 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH LAT +8T +9A 018 UR
• 00817573020027 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH LAT +8T +9A 018 UL
• 00817573020034 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS HK 0T +11A 018 UR
• 00817573020041 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS HK 0T +11A 018 UL
• 00817573020058 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS0T +11A 018 UR
• 00817573020065 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS0T +11A 018 UL
• 00817573020072 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH BIC HK -7T 0A 018 UR