CU NITANIUM® PRO FORM ARCHWIRES

GUDID 00190707068561

.014 Upper Cu Nitanium® 27° Pro Form™ Archwires

ORTHO ORGANIZERS, INC.

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire
Primary Device ID00190707068561
NIH Device Record Keyde66d6e3-ef67-4701-9967-7f52ca73d2de
Commercial Distribution StatusIn Commercial Distribution
Brand NameCU NITANIUM® PRO FORM ARCHWIRES
Version Model Number109-142
Company DUNS062165188
Company NameORTHO ORGANIZERS, INC.
Device Count1
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190707068561 [Primary]

FDA Product Code

DZCWIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-21
Device Publish Date2021-07-13

On-Brand Devices [CU NITANIUM® PRO FORM ARCHWIRES]

00190707069155.020 X .020 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069148.020 X .020 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069131.019 X .025 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069124.019 X .025 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069117.018 X .025 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069100.018 X .025 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069094.017 X .025 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069087.017 X .025 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069070.017 X .017 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069063.017 X .017 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069056.016 X .022 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069049.016 X .022 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069032.018 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069025.018 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069018.016 Lower Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707069001.016 Upper Dimpled Cu Nitanium® 35° Pro Form™ Archwires
00190707068998.016 X .025 Lower Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068981.016 X .025 Upper Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068974.016 X .022 Lower Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068967.016 X .022 Upper Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068950.014 X .025 Lower Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068943.014 X .025 Upper Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068936.018 Lower Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068929.018 Upper Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068912.016 Lower Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068905.016 Upper Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068899.014 Lower Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068882.014 Upper Dimpled Cu Nitanium® 27° Pro Form™ Archwires
00190707068875.020 X .020 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068868.020 X .020 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068851.019 X .025 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068844.019 X .025 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068837.018 X .025 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068820.018 X .025 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068813.017 X .025 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068806.017 X .025 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068790.017 X .017 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068783.017 X .017 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068776.016 X .022 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068769.016 X .022 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068752.018 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068745.018 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068738.016 Lower Cu Nitanium® 35° Pro Form™ Archwires
00190707068721.016 Upper Cu Nitanium® 35° Pro Form™ Archwires
00190707068714.019 X .025 Lower Cu Nitanium® 27° Pro Form™ Archwires
00190707068707.019 X .025 Upper Cu Nitanium® 27° Pro Form™ Archwires
00190707068691.017 X .025 Lower Cu Nitanium® 27° Pro Form™ Archwires
00190707068684.017 X .025 Upper Cu Nitanium® 27° Pro Form™ Archwires
00190707068677.016 X .025 Lower Cu Nitanium® 27° Pro Form™ Archwires
00190707068660.016 X .025 Upper Cu Nitanium® 27° Pro Form™ Archwires

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