3M™ 415-051

GUDID 00652221078018

Unitek(TM) Traction Release Headgear Cervical Medium Denim Blue/Force 1-Patient Kt

3M UNITEK CORPORATION

Orthodontic extraoral headgear

• Primary Device ID: 00652221078018
• NIH Device Record Key: ad88d912-b17c-4db2-8ac7-64f109d84031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3M™
• Version Model Number: 415-051
• Catalog Number: 415-051
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• 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: true
• 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	00652221078018 [Primary]

FDA Product Code

• DZB: Headgear, extraoral, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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• 00652221083593: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 6 in. Multi-Print NW140 10/Pk
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• 00652221077929: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Denim Blue Ea
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