3M™ 415-018

GUDID 00652221077875

Unitek(TM) Traction Release Headgear Hi-Pull Modules Medium 5-Pair 10/Pk

3M UNITEK CORPORATION

Orthodontic extraoral headgear

• Primary Device ID: 00652221077875
• NIH Device Record Key: 03ab5b47-b52e-4e1c-9f73-558ee99a61d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3M™
• Version Model Number: 415-018
• Catalog Number: 415-018
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• Device Count: 10
• 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	00652221077875 [Primary]
GS1	80652221077871 [Unit of Use]

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

On-Brand Devices [3M™]

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• 00652221236548: APC™ PLUS Clarity™ ADVANCED Victory Series™ Low Profile MBT™ Appliance System U/L 022 6x
• 00652221236401: APC™ Flash-Free Clarity™ ADVANCED MBT™ Appliance System U/L 6x7 022 1 Case Kit CHk
• 00652221236395: APC™ II Clarity™ ADVANCED MBT™ Appliance System U/L 6x7 022 1 Case Kit CHk
• 00652221236388: APC™ Flash-Free Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Kit C
• 00652221236371: APC™ II Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Kit CHk
• 00652221232922: Clarity™ ADVANCED Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Ki
• 00652221153593: Unitek(TM) TAD Cap Elastic Ring Ea
• 00652221153579: Unitek(TM) TAD O-Cap Ea
• 00652221139306: Unitek(TM) Etching Gel System 2-Syringe w/Metal Dispensing Tip Kt
• 00652221109019: Unitek(TM) Etching Gel System 2-Syringe w/Plastic Dispensing Tip Kt
• 00652221107893: Unitek(TM) Silver Solder Heavy 025 2DWT Ea
• 00652221107886: Unitek(TM) Silver Solder Reg 015 2DWT Ea
• 00652221107879: Unitek(TM) Silver Solder Lt 010 2DWT Ea
• 00652221083715: Unitek(TM) NWO Snap-Way Headgear High-Pull Release Modules 16-32 oz. NW341 1-Pair 2/Pk
• 00652221083708: Unitek(TM) NWO Snap-Way Headgear High-Pull Release Modules 10-22 oz. NW340 1-Pair 2/Pk
• 00652221083692: NWO(TM) Snap-Way(TM) System Cervical Headgear Neckpad 7 in. Denim Blue / Release Modules 16-32 o
• 00652221083685: Unitek(TM) NWO Snap-Way Headgear High-Pull Cap Multi-Print NW340 Ea
• 00652221083678: Unitek(TM) NWO Snap-Way Headgear High-Pull Cap Black NW340 Ea
• 00652221083661: Unitek(TM) NWO Snap-Way Headgear High-Pull Cap Denim Blue NW340 Ea
• 00652221083647: Unitek(TM) NWO Snap-Way Headgear Cervical Modules 16-32 oz. NW140 10-Pair 20/Pk
• 00652221083623: Unitek(TM) NWO Snap-Way Headgear Cervical Modules 10-22 oz. NW140 10-Pair 20/Pk
• 00652221083609: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 7 in. Multi-Print NW140 10/Pk
• 00652221083593: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 6 in. Multi-Print NW140 10/Pk
• 00652221083579: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 7 in. Denim Blue NW140 10/Pk
• 00652221083555: Unitek(TM) NWO Snap-Way Headgear Cervical Pad 6 in. Denim Blue NW140 10/Pk
• 00652221078100: Unitek(TM) Traction Release Headgear Hi-Pull C-Clips 60/Pk
• 00652221078094: Unitek(TM) Traction Release Headgear Hi-Pull Modules Medium 30-Pair 60/Pk
• 00652221078087: Unitek(TM) Traction Release Headgear Hi-Pull Cap Multi-Print 15-Small/15-Large Kt
• 00652221078070: Unitek(TM) Traction Release Headgear Hi-Pull Cap Denim Blue 15-Small/15-Large Kt
• 00652221078063: Unitek(TM) Traction Release Headgear Cervical Modules Medium 30-Pair 60/Pk
• 00652221078056: Unitek(TM) Traction Release Headgear Cervical C-Clips 60/Pk
• 00652221078049: Unitek(TM) Traction Release Headgear Hi-Pull Large Denim Blue/Medium Force 1-Patient Kt
• 00652221078032: Unitek(TM) Traction Release Headgear Hi-Pull Assorted Colors/Medium Force 8-Patient Kt
• 00652221078025: Unitek(TM) Traction Release Headgear Hi-Pull Assorted Colors/Forces 8-Patient Kt
• 00652221078018: Unitek(TM) Traction Release Headgear Cervical Medium Denim Blue/Force 1-Patient Kt
• 00652221078001: Unitek(TM) Traction Release Headgear Cervical Assorted Colors/Medium Force 10-Patient Kt
• 00652221077998: Unitek(TM) Traction Release Headgear Cervical Assorted Colors/Forces 10-Patient Kt
• 00652221077981: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Multi-Print Ea
• 00652221077974: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Multi-Print Ea
• 00652221077967: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Black Ea
• 00652221077950: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Black Ea
• 00652221077943: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Khaki Ea
• 00652221077936: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Khaki Ea
• 00652221077929: Unitek(TM) Traction Release Headgear Hi-Pull Cap Large Denim Blue Ea
• 00652221077912: Unitek(TM) Traction Release Headgear Hi-Pull Cap Small Denim Blue Ea
• 00652221077899: Unitek(TM) Traction Release Headgear Hi-Pull Modules Heavy 5-Pair 10/Pk
• 00652221077875: Unitek(TM) Traction Release Headgear Hi-Pull Modules Medium 5-Pair 10/Pk
• 00652221077851: Unitek(TM) Traction Release Headgear Hi-Pull Modules Light 5-Pair 10/Pk
• 00652221077837: Unitek(TM) Traction Release Headgear Cervical Modules Heavy 5-Pair 10/Pk