InBrace Teeth Straightening System (Gen 2.0) 85003

GUDID 00850018135054

SWIFT HEALTH SYSTEMS INC.

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal 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 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: 00850018135054
• NIH Device Record Key: b15e1541-b71c-4949-b462-b5f881efac5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InBrace Teeth Straightening System (Gen 2.0)
• Version Model Number: Lower Patient Kit
• Catalog Number: 85003
• 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: false
• 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	00850018135054 [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: 2021-11-15
• Device Publish Date: 2021-11-07

On-Brand Devices [InBrace Teeth Straightening System (Gen 2.0)]

• 00850018135054: Lower Patient Kit
• 00850018135047: Patient Kit
• 00850018135030: Upper Patient Kit