Unitek™ Gemini Clear Unitek™ Gemini 117-106

GUDID 00652221227409

Unitek(TM) Gemini Clear Ceramic / Gemini Bracket MBT(TM) U/L 5x5 3,4,5Hk .022 Kt

3M UNITEK CORPORATION

Orthodontic bracket, ceramic

• Primary Device ID: 00652221227409
• NIH Device Record Key: 18ce3266-7080-46f8-8116-8d05d8818893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unitek™ Gemini Clear Unitek™ Gemini
• Version Model Number: 117-106
• Catalog Number: 117-106
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• 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: 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

Customer Support Contacts

• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00652221227409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944286

FDA Product Code

• DYW: BRACKET, PLASTIC, ORTHODONTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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