Equa-Pull

GUDID 00817573023806

EQUA-PULL HEADGEAR BLACK HEAVY

LANCER ORTHODONTICS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00817573023806
• NIH Device Record Key: 9c096daf-4c5e-45c5-a6a1-150b85d63b93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equa-Pull
• Version Model Number: 830-042
• 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	00817573023806 [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 [Equa-Pull]

• 00817573023929: EQUA-PULL SAFETY BLACK 24oz 10/PK
• 00817573023912: EQUA-PULL SAFETY BLACK 12oz 10/PK
• 00817573023806: EQUA-PULL HEADGEAR BLACK HEAVY
• 00817573023790: EQUA-PULL HEADGEAR BLACK LIGHT