GUDID 00817573024261

PROTRACTION FACE MASK BLUE

LANCER ORTHODONTICS, INC.

Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear

• Primary Device ID: 00817573024261
• NIH Device Record Key: 65d5b2df-0768-4217-a287-529a3b6d58bc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 830-704B
• 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	00817573024261 [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