Smartwire InGager 85001

GUDID 00850018135399

An orthodontic reusable instrument intended for use with the InBrace Teeth Straightening System (Gen 2.0) to insert, ligate and remove Smartwires from brackets.

SWIFT HEALTH SYSTEMS INC.

Self-ligating orthodontic bracket open/close tool

• Primary Device ID: 00850018135399
• NIH Device Record Key: 2d62858b-0381-45f2-8397-ba49505e1aeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smartwire InGager
• Version Model Number: 85001
• Catalog Number: 85001
• 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: false
• 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	00850018135399 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

[00850018135399]

Moist Heat or Steam Sterilization

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

Devices Manufactured by SWIFT HEALTH SYSTEMS INC.

• 00850018135122 - Inbrace Teeth Straightening System: 2022-10-11
• 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