Inbrace Teeth Straightening System 8131

GUDID 00850018135122

SWIFT HEALTH SYSTEMS INC.

Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit Orthodontic appliance/positioning tray kit

• Primary Device ID: 00850018135122
• NIH Device Record Key: 861d3d42-a09e-4e48-89d9-c73ed35f98e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inbrace Teeth Straightening System
• Version Model Number: Digital Engancement
• Catalog Number: 8131
• Company DUNS: 884398210
• Company Name: SWIFT HEALTH SYSTEMS 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850018135122 [Primary]

FDA Product Code

• PNN: Orthodontic Software

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: 2022-10-11
• Device Publish Date: 2022-10-03

On-Brand Devices [Inbrace Teeth Straightening System ]

• 00850018135139: Lower Patient Kit
• 00850018135016: Upper Patient Kit
• 00850018135009: Standard Patient Kit
• 00850018135122: Digital Engancement