3M™ Unitek™ 001-374

GUDID 00652221002198

Unitek(TM) Standard Edgewise Bracket Single Narrow U/L Universal .022 5/Pk

3m do Brasil Ltda.

Orthodontic bracket, metal Orthodontic bracket, metal

• Primary Device ID: 00652221002198
• NIH Device Record Key: b2ec2645-4f89-42cc-9a51-ef38aea415ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3M™ Unitek™
• Version Model Number: 001-374
• Catalog Number: 001-374
• Company DUNS: 901611820
• Company Name: 3m do Brasil Ltda.
• 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: 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	00652221002198 [Primary]
GS1	80652221002194 [Unit of Use]

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: 2018-10-25
• Device Publish Date: 2018-09-24

On-Brand Devices [3M™ Unitek™]

• 00652221235992: Unitek(TM) Miniature Twin Bracket Roth LR3 -11T/5A .022 50/Pk
• 00652221235985: Unitek(TM) Miniature Twin V-Slot Bracket Roth U3,4,5/L3,4,5 0T/0A .018 50/Pk
• 00652221235978: Unitek(TM) Miniature Twin Bracket Roth L4 -17T/0A .018 50/Pk
• 00652221235961: Unitek(TM) Miniature Twin Bracket Roth LR3 -11T/5A Hk .018 50/Pk
• 00652221235534: Unitek(TM) Miniature Twin Bracket Roth L5 -22T/0A .018 50/Pk
• 00652221235527: Unitek(TM) Miniature Twin Bracket Roth LL3 -11T/5A Hk .018 50/Pk
• 00652221235510: Unitek(TM) Miniature Twin Bracket Roth UR4,5 -7T/0A Hk .018 50/Pk
• 00652221235503: Unitek(TM) Miniature Twin Bracket Roth UL4,5 -7T/0A Hk .018 50/Pk
• 00652221235497: Unitek(TM) Miniature Twin Bracket Roth UR3 0T/11A Hk .018 50/Pk
• 00652221235480: Unitek(TM) Miniature Twin Bracket Roth UL3 0T/11A Hk .018 50/Pk
• 00652221235473: Unitek(TM) Miniature Twin Bracket Roth UL2 8T/9A .018 50/Pk
• 00652221235039: Unitek(TM) Miniature Twin Bracket Roth UR1 12T/5A .018 50/Pk
• 00652221235022: Unitek(TM) Miniature Twin Bracket Roth UL1 12T/5A .018 50/Pk
• 00652221234926: Unitek(TM) Miniature Twin Bracket Roth U4,5 -7T/0A .018 50/Pk
• 00652221234919: Unitek(TM) Miniature Twin Bracket Roth UR2 8T/9A .018 50/Pk
• 00652221234742: Unitek(TM) Miniature Twin Bracket Roth LR3 -11T/5A Hk .022 50/Pk
• 00652221234735: Unitek(TM) Miniature Twin V-Slot Metal Bracket Roth L1,2 -1T/0A .018 50/Pk
• 00652221234490: Unitek(TM) Miniature Twin Bracket Roth LL3 -11T/5A Hk .022 50/Pk
• 00652221234483: Unitek(TM) Miniature Twin Bracket Roth UR3 0T/11A Hk .022 50/Pk
• 00652221234353: Unitek(TM) Miniature Twin Bracket Roth L4 -17T/0A .022 50/Pk
• 00652221234315: Unitek(TM) Miniature Twin Bracket Roth UL3 0T/11A Hk .022 50/Pk
• 00652221234230: Unitek(TM) Miniature Twin Bracket Roth UR2 8T/9A .022 50/Pk
• 00652221233301: Unitek(TM) Miniature Twin Bracket Roth L5 -22T/0A .022 50/Pk
• 00652221233295: Unitek(TM) Miniature Twin Metal Bracket Roth L1,2 -1T/0A .022 50/Pk
• 00652221233288: Unitek(TM) Miniature Twin Bracket Roth U4,5 -7T/0A .022 50/Pk
• 00652221233271: Unitek(TM) Miniature Twin Bracket Roth UL2 8T/9A .022 50/Pk
• 00652221233264: Unitek(TM) Miniature Twin Bracket Roth UR1 12T/5A .022 50/Pk
• 00652221233257: Unitek(TM) Miniature Twin Metal Bracket Roth L1,2 -1T/0A .018 50/Pk
• 00652221233240: Unitek(TM) Miniature Twin Bracket Roth UL1 12T/5A .022 50/Pk
• 00652221007254: Unitek(TM) Miniature Twin V-Slot Bracket Roth LR3 -11T/5A Hk .022 5/Pk
• 00652221007247: Unitek(TM) Miniature Twin V-Slot Bracket Roth LL3 -11T/5A Hk .022 5/Pk
• 00652221007230: Unitek(TM) Miniature Twin V-Slot Bracket Roth UR3 0T/11A Hk .022 5/Pk
• 00652221007223: Unitek(TM) Miniature Twin V-Slot Bracket Roth UL3 0T/11A Hk .022 5/Pk
• 00652221007216: Unitek(TM) Miniature Twin Bracket Roth LR3 -11T/5A 6DistalRotation Hk .022 5/Pk
• 00652221007209: Unitek(TM) Miniature Twin Bracket Roth LL3 -11T/5A 6DistalRotation Hk .022 5/Pk
• 00652221007193: Unitek(TM) Miniature Twin Bracket Roth LR3 -11T/5A 6DistalRotation .022 5/Pk
• 00652221007186: Unitek(TM) Miniature Twin Bracket Roth LL3 -11T/5A 6DistalRotation .022 5/Pk
• 00652221006400: Unitek(TM) Miniature Twin V-Slot Bracket Roth LR3 -11T/5A Hk .018 5/Pk
• 00652221006394: Unitek(TM) Miniature Twin V-Slot Bracket Roth LL3 -11T/5A Hk .018 5/Pk
• 00652221006387: Unitek(TM) Miniature Twin V-Slot Bracket Roth UR3 0T/11A Hk .018 5/Pk
• 00652221006370: Unitek(TM) Miniature Twin V-Slot Bracket Roth UL3 0T/11A Hk .018 5/Pk
• 00652221006363: Unitek(TM) Miniature Twin Bracket Roth LR3 -11T/5A 6DistalRotation Hk .018 5/Pk
• 00652221006356: Unitek(TM) Miniature Twin Bracket Roth LL3 -11T/5A 6DistalRotation Hk .018 5/Pk
• 00652221006325: Unitek(TM) Miniature Twin V-Slot Metal Bracket Roth L1,2 0T/0A .022 5/Pk
• 00652221006318: Unitek(TM) Miniature Twin V-Slot Bracket Roth U2 0T/0A .022 5/Pk
• 00652221006301: Unitek(TM) Miniature Twin V-Slot Bracket Roth U1 0T/0A .022 5/Pk
• 00652221006295: Unitek(TM) Miniature Twin V-Slot Bracket Roth U3,4,5/L3,4,5 0T/0A .022 5/Pk
• 00652221006288: Unitek(TM) Miniature Twin V-Slot Bracket Roth L5 -22T/0A .022 5/Pk
• 00652221006271: Unitek(TM) Miniature Twin V-Slot Bracket Roth L4 -17T/0A .022 5/Pk
• 00652221006264: Unitek(TM) Miniature Twin V-Slot Bracket Roth LR3 -11T/5A .022 5/Pk