APC™ II Unitek™ Gemini 3119-663

GUDID 00652221067739

Unitek(TM) Gemini Bracket APC(TM) II Roth LL3 0T/6A Hk .018 5/Pk

3M UNITEK CORPORATION

Orthodontic bracket, metal Orthodontic bracket, metal
Primary Device ID00652221067739
NIH Device Record Keyc2cc6959-b218-448e-a95d-dd431cba082d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC™ II Unitek™ Gemini
Version Model Number3119-663
Catalog Number3119-663
Company DUNS008256356
Company Name3M UNITEK CORPORATION
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
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
GS100652221067739 [Primary]
GS180652221067735 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-04

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

00652221226792Unitek(TM) Gemini SL Bracket APC(TM) II MBT(TM) U/L 5x5 3,4,5Hk .022 Kt
00652221226785Unitek(TM) Gemini SL Bracket APC(TM) II Roth U/L 5x5 3,4,5Hk .018 Kt
00652221226778Unitek(TM) Gemini SL Bracket APC(TM) II Roth U/L 5x5 3,4,5Hk .022 Kt
00652221226761Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A Hk .018 5/Pk
00652221226754Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A Hk .018 5/Pk
00652221226747Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A .018 5/Pk
00652221226730Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A .018 5/Pk
00652221226723Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR4 -17T/2A Hk .018 5/Pk
00652221226716Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL4 -17T/2A Hk .018 5/Pk
00652221226709Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR4 -17T/2A .018 5/Pk
00652221226693Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL4 -17T/2A .018 5/Pk
00652221226686Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A Hk .018 5/Pk
00652221226679Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A Hk .018 5/Pk
00652221226662Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A .018 5/Pk
00652221226655Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A .018 5/Pk
00652221226648Unitek(TM) Gemini SL Bracket APC(TM) II Roth L1,2 0T/0A .018 5/Pk
00652221226631Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR4,5 -7T/0A Hk .018 5/Pk
00652221226624Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL4,5 -7T/0A Hk .018 5/Pk
00652221226617Unitek(TM) Gemini SL Bracket APC(TM) II Roth U4,5 -7T/0A .018 5/Pk
00652221226600Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A Hk .018 5/Pk
00652221226594Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A Hk .018 5/Pk
00652221226587Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A .018 5/Pk
00652221226570Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A .018 5/Pk
00652221226563Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR2 8T/9A .018 5/Pk
00652221226556Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL2 8T/9A .018 5/Pk
00652221226549Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR1 12T/5A .018 5/Pk
00652221226532Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL1 12T/5A .018 5/Pk
00652221226525Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A Hk .022 5/Pk
00652221226518Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A Hk .022 5/Pk
00652221226501Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR5 -22T/2A .022 5/Pk
00652221226495Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A .022 5/Pk
00652221226488Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR4 -17T/2A Hk .022 5/Pk
00652221226471Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL4 -17T/2A Hk .022 5/Pk
00652221226464Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR 1st4,5 -17T/2A .022 5/Pk
00652221226457Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL 1st4,5 -17T/2A .022 5/Pk
00652221226440Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A Hk .022 5/Pk
00652221226433Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A Hk .022 5/Pk
00652221226426Unitek(TM) Gemini SL Bracket APC(TM) II Roth LR3 -11T/5A .022 5/Pk
00652221226419Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL3 -11T/5A .022 5/Pk
00652221226402Unitek(TM) Gemini SL Bracket APC(TM) II Roth L1,2 0T/0A .022 5/Pk
00652221226396Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR4,5 -7T/0A Hk .022 5/Pk
00652221226389Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL4,5 -7T/0A Hk .022 5/Pk
00652221226372Unitek(TM) Gemini SL Bracket APC(TM) II Roth U4,5 -7T/0A .022 5/Pk
00652221226365Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A Hk .022 5/Pk
00652221226358Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A Hk .022 5/Pk
00652221226341Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR3 -2T/11A .022 5/Pk
00652221226334Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL3 -2T/11A .022 5/Pk
00652221226327Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR2 8T/9A .022 5/Pk
00652221226310Unitek(TM) Gemini SL Bracket APC(TM) II Roth UL2 8T/9A .022 5/Pk
00652221226303Unitek(TM) Gemini SL Bracket APC(TM) II Roth UR1 12T/5A .022 5/Pk
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.