APC™ II Unitek™ Gemini 3027-352

GUDID 00652221226419

Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A .022 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal

• Primary Device ID: 00652221226419
• NIH Device Record Key: a5186367-b741-436f-9f9e-96cb1d80bba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC™ II Unitek™ Gemini
• Version Model Number: 3027-352
• Catalog Number: 3027-352
• Company DUNS: 008256356
• Company Name: 3M UNITEK CORPORATION
• Device Count: 5
• 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: 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
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)423-4588
• Email: 3Mhealthcarecompliance@mmm.com
• 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	00652221226419 [Primary]
GS1	80652221226415 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911271

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

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

On-Brand Devices [APC™ II Unitek™ Gemini]

• 00652221226792: Unitek(TM) Gemini SL Bracket APC(TM) II MBT(TM) U/L 5x5 3,4,5Hk .022 Kt
• 00652221226785: Unitek(TM) Gemini SL Bracket APC(TM) II Roth U/L 5x5 3,4,5Hk .018 Kt
• 00652221226778: Unitek(TM) Gemini SL Bracket APC(TM) II Roth U/L 5x5 3,4,5Hk .022 Kt
• 00652221226761: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A Hk .018 5/Pk
• 00652221226754: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A Hk .018 5/Pk
• 00652221226747: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A .018 5/Pk
• 00652221226730: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A .018 5/Pk
• 00652221226723: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR4 -17T/2A Hk .018 5/Pk
• 00652221226716: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL4 -17T/2A Hk .018 5/Pk
• 00652221226709: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR4 -17T/2A .018 5/Pk
• 00652221226693: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL4 -17T/2A .018 5/Pk
• 00652221226686: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A Hk .018 5/Pk
• 00652221226679: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A Hk .018 5/Pk
• 00652221226662: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A .018 5/Pk
• 00652221226655: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A .018 5/Pk
• 00652221226648: Unitek(TM) Gemini SL Bracket APC(TM) II Roth L1,2 0T/0A .018 5/Pk
• 00652221226631: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR4,5 -7T/0A Hk .018 5/Pk
• 00652221226624: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL4,5 -7T/0A Hk .018 5/Pk
• 00652221226617: Unitek(TM) Gemini SL Bracket APC(TM) II Roth U4,5 -7T/0A .018 5/Pk
• 00652221226600: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A Hk .018 5/Pk
• 00652221226594: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A Hk .018 5/Pk
• 00652221226587: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A .018 5/Pk
• 00652221226570: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A .018 5/Pk
• 00652221226563: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR2 8T/9A .018 5/Pk
• 00652221226556: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL2 8T/9A .018 5/Pk
• 00652221226549: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR1 12T/5A .018 5/Pk
• 00652221226532: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL1 12T/5A .018 5/Pk
• 00652221226525: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A Hk .022 5/Pk
• 00652221226518: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A Hk .022 5/Pk
• 00652221226501: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A .022 5/Pk
• 00652221226495: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A .022 5/Pk
• 00652221226488: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR4 -17T/2A Hk .022 5/Pk
• 00652221226471: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL4 -17T/2A Hk .022 5/Pk
• 00652221226464: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR 1st4,5 -17T/2A .022 5/Pk
• 00652221226457: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL 1st4,5 -17T/2A .022 5/Pk
• 00652221226440: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A Hk .022 5/Pk
• 00652221226433: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A Hk .022 5/Pk
• 00652221226426: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A .022 5/Pk
• 00652221226419: Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A .022 5/Pk
• 00652221226402: Unitek(TM) Gemini SL Bracket APC(TM) II Roth L1,2 0T/0A .022 5/Pk
• 00652221226396: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR4,5 -7T/0A Hk .022 5/Pk
• 00652221226389: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL4,5 -7T/0A Hk .022 5/Pk
• 00652221226372: Unitek(TM) Gemini SL Bracket APC(TM) II Roth U4,5 -7T/0A .022 5/Pk
• 00652221226365: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A Hk .022 5/Pk
• 00652221226358: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A Hk .022 5/Pk
• 00652221226341: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A .022 5/Pk
• 00652221226334: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A .022 5/Pk
• 00652221226327: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR2 8T/9A .022 5/Pk
• 00652221226310: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL2 8T/9A .022 5/Pk
• 00652221226303: Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR1 12T/5A .022 5/Pk