Carriere Motion Pro

GUDID 00190707102906

Carriere Motion Pro Bite Corrector 16 mm 1-Set

ORTHO ORGANIZERS, INC.

Orthodontic bracket, metal
Primary Device ID00190707102906
NIH Device Record Key26c8a2cc-2040-490d-bf08-29c3a3fe692e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarriere Motion Pro
Version Model Number425-816C
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 Datefalse
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
GS100190707102906 [Primary]
GS110190707102903 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-10-25
Device Publish Date2022-10-17

Devices Manufactured by ORTHO ORGANIZERS, INC.

00190707143107 - Band Assemblies2025-07-23 Elite.022/.045 UR6 Conv TplBT Tempra/Sheath 32.5
00190707143114 - Band Assemblies2025-07-23 Elite.022/.045 UL6 Conv TplBT Tempra/Sheath 32.5
00190707128975 - Band Assemblies2025-07-15 .022 Elite LR6 Conv DBT -25T/0A/+4Off Tempra - Cleat 44
00190707128982 - Band Assemblies2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 33
00190707128999 - Band Assemblies2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 33.5
00190707129002 - Band Assemblies2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 34
00190707129019 - Band Assemblies2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 34.5
00190707129026 - Band Assemblies2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 35

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