Lancer Gear

GUDID 00817573023882

HIGH-PULL"LANCER GEAR"BLACK/LIGHT BLUE 5/PACK

LANCER ORTHODONTICS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00817573023882
• NIH Device Record Key: 9d063e68-d2c6-413a-a434-61b042b2fe19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lancer Gear
• Version Model Number: 830-125
• 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	00817573023882 [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: 2017-01-14

On-Brand Devices [Lancer Gear]

• 00817573023905: HIGH-PULL"LANCER GEAR"BLACK/PURPLE 5/PK
• 00817573023899: HIGH-PULL"LANCER GEAR"BLACK/TEAL 5/PK
• 00817573023882: HIGH-PULL"LANCER GEAR"BLACK/LIGHT BLUE 5/PACK
• 00817573023875: HIGH-PULL"LANCER GEAR"BLACK/BLACK 5/PK
• 00817573023868: HIGH-PULL"LANCER GEAR"BLACK/PINK 5/PK
• 00817573023851: CERVICAL"LANCER GEAR"BLACK/PURPLE 5/PK
• 00817573023844: CERVICAL"LANCER GEAR"BLACK/TEAL 5/PK
• 00817573023837: CERVICAL"LANCER GEAR"BLACK/LIGHT BLUE 5/PACK
• 00817573023820: CERVICAL"LANCER GEAR"BLACK/BLACK 5/PK
• 00817573023813: CERVICAL"LANCER GEAR"BLACK/PINK 5/PK
• 00817573023783: HIGH-PULL"LANCER GEAR"BLACK/PURPLE
• 00817573023776: HIGH-PULL"LANCER GEAR"BLACK/TEAL
• 00817573023769: HIGH-PULL"LANCER GEAR"BLACK/LIGHT BLUE
• 00817573023752: HIGH-PULL"LANCER GEAR"BLACK/BLACK
• 00817573023745: HIGH-PULL"LANCER GEAR"BLACK/PINK
• 00817573023738: CERVICAL"LANCER GEAR"BLACK/PURPLE
• 00817573023721: CERVICAL"LANCER GEAR"BLACK/TEAL
• 00817573023714: CERVICAL"LANCER GEAR"BLACK/LIGHT BLUE
• 00817573023707: CERVICAL"LANCER GEAR"BLACK/BLACK
• 00817573023691: CERVICAL"LANCER GEAR"BLACK/PINK