InBrace Teeth Straightening System (Gen 2.0) 85003

GUDID 00850018135054

SWIFT HEALTH SYSTEMS INC.

Orthodontic bracket, metal

• 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