3M™ Unitek™ 163-479

GUDID 00652221046628

Unitek(TM) Molar Band General Purpose Wide Hard Temper L6,7 Size 139+ Ea

3M UNITEK CORPORATION

Orthodontic metal band Orthodontic metal band
Primary Device ID00652221046628
NIH Device Record Key203ed96d-39b7-4654-b05a-99d8f2ba2cd2
Commercial Distribution StatusIn Commercial Distribution
Brand Name3M™ Unitek™
Version Model Number163-479
Catalog Number163-479
Company DUNS008256356
Company Name3M UNITEK CORPORATION
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)423-4588
Email3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100652221046628 [Primary]
GS180652221046624 [Unit of Use]

FDA Product Code

ECMBAND, PREFORMED, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-18

On-Brand Devices [3M™ Unitek™]

00652221289445358-901 CTA Digital Workflow EA
006522212370643M (TM) Unitek (TM) Open-Close Instrument for the Ultra SL Sys
006522212365623M (TM) UNITEK (TM) DEBONDING INSTRUMENT FOR ULTRA SL SYSTEM
00652221164261Unitek(TM) Ligature Ties Preformed Tooth Colored Shorty .012 .in 100/Pk
00652221128140Unitek(TM) Nitinol Super-Elastic Reverse Curve L .020 10/Pk
00652221128133Unitek(TM) Nitinol Super-Elastic Reverse Curve U .020 10/Pk
00652221128126Unitek(TM) Nitinol Super-Elastic Reverse Curve L .016x.025 10/Pk
00652221128119Unitek(TM) Nitinol Super-Elastic Reverse Curve U .016x.025 10/Pk
00652221073099Ligature Wire Preformed Coated Natural .012 .in 100/Pk
00652221073075Auxiliary Ligature Tie Hook .014 in. 100/Pk
00652221073068Ligature Wire Preformed .014 in. 1000/Pk
00652221073051Ligature Wire Preformed .012 in. 1000/Pk
00652221073044Ligature Wire Preformed .011 in. 1000/Pk
00652221073037Ligature Wire Preformed .010 in. 1000/Pk
00652221073020Ligature Wire Preformed .009 in. 1000/Pk
00652221073013Ligature Wire Preformed .008 in. 1000/Pk
00652221073006Ball Retainer Clasp .040 10/Pk
00652221072993Ball Retainer Clasp .032 10/Pk
00652221072986Ball Retainer Clasp .028 10/Pk
00652221072979Ball Retainer Clasp .024 10/Pk
00652221072962Modified Arrowhead Clasp 12 mm x .028 10/Pk
00652221072955Modified Arrowhead Clasp 11 mm x .028 10/Pk
00652221072948Modified Arrowhead Clasp 10 mm x .028 10/Pk
00652221072931Modified Arrowhead Clasp 9 mm x .028 10/Pk
00652221072924Modified Arrowhead Clasp 8 mm x .028 10/Pk
00652221072917Modified Arrowhead Clasp 7 mm x .028 10/Pk
00652221072900Modified Arrowhead Clasp 6 mm x .028 10/Pk
00652221072894Modified Arrowhead Clasp 6.5 mm x .024 10/Pk
00652221072887Modified Arrowhead Clasp 5.5 mm x .024 10/Pk
00652221072870Unitek(TM) Hawley Retainer Size 9 Ea
00652221072863Unitek(TM) Hawley Retainer Size 8 Ea
00652221072856Unitek(TM) Hawley Retainer Size 7 Ea
00652221072849Unitek(TM) Hawley Retainer Size 6 Ea
00652221072832Unitek(TM) Hawley Retainer Size 5 Ea
00652221072825Unitek(TM) Hawley Retainer Size 4 Ea
00652221072818Unitek(TM) Hawley Retainer Size 3 Ea
00652221072801Unitek(TM) Hawley Retainer Size 2 Ea
00652221072795Unitek(TM) Hawley Retainer Size 1 Ea
00652221072788Unitek(TM) Hawley Retainer Size 0 Ea
00652221071903Unitek(TM) Nitinol Closed Coil Spring 12 mm Heavy 10/Pk
00652221071897Unitek(TM) Nitinol Closed Coil Spring 12 mm Medium 10/Pk
00652221071880Unitek(TM) Nitinol Closed Coil Spring 12 mm Light 10/Pk
00652221071873Unitek(TM) Nitinol Open Coil Spring 17.5 mm Heavy 3/Pk
00652221071866Unitek(TM) Nitinol Open Coil Spring 17.5 mm Medium 3/Pk
00652221071859Nitinol Open Coil Spring 7 in. Light .030 mm 3/Pk
00652221071842Unitek(TM) Nitinol Closed Coil Spring 9 mm Heavy 10/Pk
00652221071835Unitek(TM) Nitinol Closed Coil Spring 9 mm Medium 10/Pk
00652221071828Unitek(TM) Nitinol Closed Coil Spring 9 mm Light 10/Pk
00652221054685Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .020 50/Pk
00652221054678Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .018 50/Pk

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