Straight-Wire Synthesis

GUDID 10889989013426

U3L SWS DB/OM 22 HK ANDREWS CUSPID 11/-7

ORMCO CORPORATION

Orthodontic bracket, metal
Primary Device ID10889989013426
NIH Device Record Keya9cc4d8f-a498-4ded-bf80-607f7d1288db
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraight-Wire Synthesis
Version Model Number339-1321
Company DUNS154614119
Company NameORMCO 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100889989013429 [Primary]
GS110889989013426 [Unit of Use]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

On-Brand Devices [Straight-Wire Synthesis]

10889989013945L5L SWS DB/OM 22 D/G HK ANDREWS NON G-OFF 2/-22/0
10889989013938L5R SWS DB/OM 22 D/G HK ANDREWS NON G-OFF 2/-22/0
10889989013921L5L SWS DB/OM 22 M/G HK ANDREWS NON G-OFF 2/-22/0
10889989013914L5R SWS DB/OM 22 M/G HK ANDREWS NON G-OFF 2/-22/0
10889989013907L5L SWS DB/OM 22 D/G HK ANDREWS G-OFF BI 2/-22/0
10889989013891L5R SWS DB/OM 22 D/G HK ANDREWS G-OFF BI 2/-22/0
10889989013884L5L SWS DB/OM 22 M/G HK AND G-OFF BI 2/-22
10889989013877L5R SWS DB/OM 22 M/G HK AND G-OFF BI 2/-22
10889989013860L4L SWS DB/OM 22 D/G HK ANDREWS NON G-OFF 2/-17/0
10889989013853L4R SWS DB/OM 22 D/G HK ANDREWS NON G-OFF 2/-17/0
10889989013846L4L SWS DB/OM 22 M/G HK ANDREWS NON G-OFF 2/-17/0
10889989013839L4R SWS DB/OM 22 M/G HK ANDREWS NON G-OFF 2/-17/0
10889989013822L4L SWS DB/OM 22 D/G HK ANDREWS G-OFF BI 2/-17/0
10889989013815L4R SWS DB/OM 22 D/G HK ANDREWS G-OFF BI 2/-17/0
10889989013808L4L SWS DB/OM 22 M/G HK AND G-OFF BI 2/-17
10889989013792L4R SWS DB/OM 22 M/G HK AND G-OFF BI 2/-17
10889989013785U4 and5L SWS DB/OM 22 D/G HK ANDREWS NON G-OFF 2/-7/0
10889989013778U4 and 5R SWS DB/OM 22 D/G HK ANDREWS NON G-OFF 2/-7/0
10889989013761U4 and 5L SWS DB/OM 22 M/B HK ANDREWS NON G-OFF 2/-7/0
10889989013754U4 and 5R SWS DB/OM 22 M/B HK ANDREWS NON G-OFF 2/-7/0
10889989013747U4 and 5L SWS DB/OM 22 M/G HK ROTH NON G-OFF 0/-7/2
10889989013730U4 and 5R SWS DB/OM 22 M/G HK ROTH NON G-OFF 0/-7/2
10889989013723U4 and 5L SWS DB/OM 22 D/G HK ANDREWS G-OFF BI 2/-7/0
10889989013716U4 and 5R SWS DB/OM 22 D/G HK ANDREWS G-OFF BI 2/-7/0
10889989013709U4 and 5L SWS DB/OM 22 M/G HK AND G-OFF BI 2/-7
10889989013693U4 and 5R SWS DB/OM 22 M/G HK AND G-OFF BI 2/-7
10889989013686U4 and 5L SWS DB/OM 22 M/G HK ROTH G-OFF BICUSPID 0/-7/2
10889989013679U4 and 5R SWS DB/OM 22 M/G HK ROTH G-OFF BICUSPID 0/-7/2
10889989013662L5L SWS DB/OM 22 D/G HK ROTH NON G-OFF -1/-22/4
10889989013655L5R SWS DB/OM 22 D/G HK ROTH NON G-OFF -1/-22/4
10889989013624L5L SWS DB/OM 22 D/G HK ROTH G-OFF 2BI -1/-22/4
10889989013617L5R SWS DB/OM 22 D/G HK ROTH G-OFF 2BI -1/-22/4
10889989013600L4L SWS DB/OM 22 D/G HK ROTH NON G-OFF -1/-17/4
10889989013594L4R SWS DB/OM 22 D/G HK ROTH NON G-OFF -1/-17/4
10889989013587L4L SWS DB/OM 22 D/G HK ROTH G-OFF 1BI -1/-17/4
10889989013570L4R SWS DB/OM 22 D/G HK ROTH G-OFF 1BI -1/-17/4
10889989013563U4 and 5L SWS DB/OM 22 D/G HK ROTH NON G-OFF 0/-7/2
10889989013556U4 and 5R SWS DB/OM 22 D/G HK ROTH NON G-OFF 0/-7/2
10889989013532U5R SWS BIC TUBE 22 G/O -7T,1A
10889989013525U4 and 5L SWS DB/OM 22 D/G HK ROTH G-OFF BI 0/-7/2
10889989013518U4 and 5R SWS DB/OM 22 D/G HK ROTH G-OFF BI 0/-7/2
10889989013501L3L SWS DB/OM 22 HK ANDREWS CUSPID 5/-11
10889989013495L3R SWS DB/OM 22 HK ANDREWS CUSPID 5/-11
10889989013488L3L SWS DB/OM 22 HK ROTH CUSPID 7/-11/2
10889989013471L3R SWS DB/OM 22 HK ROTH CUSPID 7/-11/2
10889989013464U3L SWS DB/OM 22 HK SPECIAL CUSPID 9/-2/4
10889989013457U3R SWS DB/OM 22 HK SPECIAL CUSPID 9/-2/4
10889989013440U3L SWS DB/OM 22 HK SUPER TORQUE CUSPID 9/3/4
10889989013433U3R SWS DB/OM 22 HK SUPER TORQUE CUSPID 9/3/4
10889989013426U3L SWS DB/OM 22 HK ANDREWS CUSPID 11/-7
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