Carriere® MOTION 3D™

GUDID 00190707086626

Carriere® MOTION 3D™ Hands-On Training Supplies - CLEAR, no instrument - For Training Purposes Only

ORTHO ORGANIZERS, INC.

Orthodontic bracket, plastic, single-use

• Primary Device ID: 00190707086626
• NIH Device Record Key: 6e250fa4-cbb0-473c-a3c1-a9c401f17628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carriere® MOTION 3D™
• Version Model Number: 633-424CNI
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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	00190707086626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160720

FDA Product Code

• DYW: BRACKET, PLASTIC, ORTHODONTIC

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: 2020-07-21
• Device Publish Date: 2020-07-13

On-Brand Devices [Carriere® MOTION 3D™]

• 00190707086633: Carriere® MOTION 3D™ Hands-On Training Supplies - SILVER, no instrument - For Training Purpos
• 00190707086626: Carriere® MOTION 3D™ Hands-On Training Supplies - CLEAR, no instrument - For Training Purpose