InBrace Starter Kit 83000

GUDID 10850018135396

This device is a kit containing 3 Smartwire InGager instruments and spare brackets for use with InBrace Teeth Straightening System (Gen 2.0)

SWIFT HEALTH SYSTEMS INC.

Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool Self-ligating orthodontic bracket open/close tool

• Primary Device ID: 10850018135396
• NIH Device Record Key: b66c7f9d-f717-4516-ba05-bc0bc52cfa43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InBrace Starter Kit
• Version Model Number: 83000
• Catalog Number: 83000
• Company DUNS: 884398210
• Company Name: SWIFT HEALTH SYSTEMS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	10850018135396 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

[10850018135396]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-02
• Device Publish Date: 2021-11-24

Devices Manufactured by SWIFT HEALTH SYSTEMS INC.

• 00850018135122 - Inbrace Teeth Straightening System: 2022-10-11
• 10850018135396 - InBrace Starter Kit: 2021-12-02This device is a kit containing 3 Smartwire InGager instruments and spare brackets for use with InBrace Teeth Straightening System (Gen 2.0)
• 10850018135396 - InBrace Starter Kit: 2021-12-02 This device is a kit containing 3 Smartwire InGager instruments and spare brackets for use with InBrace Teeth Straightening Syst
• 00850018135009 - Inbrace Teeth Straightening System: 2021-11-15
• 00850018135016 - Inbrace Teeth Straightening System: 2021-11-15
• 00850018135030 - InBrace Teeth Straightening System (Gen 2.0): 2021-11-15
• 00850018135047 - InBrace Teeth Straightening System (Gen 2.0): 2021-11-15
• 00850018135054 - InBrace Teeth Straightening System (Gen 2.0): 2021-11-15
• 00850018135139 - Inbrace Teeth Straightening System: 2021-11-15