Carriere Motion Pro

GUDID 00190707102906

Carriere Motion Pro Bite Corrector 16 mm 1-Set

ORTHO ORGANIZERS, INC.

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• Primary Device ID: 00190707102906
• NIH Device Record Key: 26c8a2cc-2040-490d-bf08-29c3a3fe692e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carriere Motion Pro
• Version Model Number: 425-816C
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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	00190707102906 [Primary]
GS1	10190707102903 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160720

FDA Product Code

• EJF: BRACKET, METAL, 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: 2022-10-25
• Device Publish Date: 2022-10-17

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