ORTHO ALIGNER TRAY SEATERS

GUDID D89260705400303

MAXILL, INC.

Orthodontic positioner seater

• Primary Device ID: D89260705400303
• NIH Device Record Key: a2ff8adf-9525-4df9-b51e-22011ba61b9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO ALIGNER TRAY SEATERS
• Version Model Number: 6070540030
• Company DUNS: 079343581
• Company Name: MAXILL, INC.
• Device Count: 20
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D89260705400301 [Unit of Use]
HIBCC	D89260705400302 [Primary]
HIBCC	D89260705400303 [Package]; Contains: D89260705400302; Package: Case [2000 Units]; In Commercial Distribution

FDA Product Code

• ECS: Pusher, Band, Orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-16
• Device Publish Date: 2022-09-08

On-Brand Devices [ORTHO ALIGNER TRAY SEATERS]

• D89260705400323: 6070540032
• D89260705400313: 6070540031
• D89260705400303: 6070540030