APC™ II Unitek™ Gemini Clear 3117-405

GUDID 00652221169273

Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL3 0T/8A Hk .018 Ea

3M UNITEK CORPORATION

Orthodontic bracket, ceramic Orthodontic bracket, ceramic
Primary Device ID00652221169273
NIH Device Record Keyfd3944c3-338a-4dd1-acb4-f870edbcbe84
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC™ II Unitek™ Gemini Clear
Version Model Number3117-405
Catalog Number3117-405
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
GS100652221169273 [Primary]
GS180652221169279 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYWBRACKET, PLASTIC, ORTHODONTIC

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 Clear]

00652221217905Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U/L 3x3 3Hk .018 Kt
00652221217899Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U/L 3x3 3Hk .018 Kt
00652221217882Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U 3x3 3Hk .018 Kt
00652221217875Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U 3x3 3Hk .022 Kt
00652221169419Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U/L 5x5 3,4,5Hk .018 Kt
00652221169402Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U/L 5x5 3,4,5Hk .022 Kt
00652221169372Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR4,5 -7T/0A Hk .018 Ea
00652221169365Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LR5 -17T/2A Hk .018 Ea
00652221169358Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LL5 -17T/2A Hk .018 Ea
00652221169341Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LR4 -12T/2A Hk .018 Ea
00652221169334Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LL4 -12T/2A Hk .018 Ea
00652221169327Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LR3 0T/3A Hk .018 Ea
00652221169310Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LL3 0T/3A Hk .018 Ea
00652221169303Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) L1,2 -6T/0A .018 Ea
00652221169297Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL4,5 -7T/0A Hk .018 Ea
00652221169280Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR3 0T/8A Hk .018 Ea
00652221169273Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL3 0T/8A Hk .018 Ea
00652221169266Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR2 10T/8A .018 Ea
00652221169259Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL2 10T/8A .018 Ea
00652221169242Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR1 17T/4A .018 Ea
00652221169235Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL1 17T/4A .018 Ea
00652221169228Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR4,5 -7T/0A Hk .022 Ea
00652221169211Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LR5 -17T/2A Hk .022 Ea
00652221169204Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LL5 -17T/2A Hk .022 Ea
00652221169198Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LR4 -12T/2A Hk .022 Ea
00652221169181Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LL4 -12T/2A Hk .022 Ea
00652221169174Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LR3 0T/3A Hk .022 Ea
00652221169167Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) LL3 0T/3A Hk .022 Ea
00652221169150Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) L1,2 -6T/0A .022 Ea
00652221169143Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL4,5 -7T/0A Hk .022 Ea
00652221169136Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR3 0T/8A Hk .022 Ea
00652221169129Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL3 0T/8A Hk .022 Ea
00652221169112Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR2 10T/8A .022 Ea
00652221169105Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL2 10T/8A .022 Ea
00652221169099Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UR1 17T/4A .022 Ea
00652221169082Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) UL1 17T/4A .022 Ea
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