Carriere

GUDID 00190707005764

Carriere® MOTION 3D CLEAR™ Class II 27mm

ORTHO ORGANIZERS, INC.

Orthodontic bracket, plastic, single-use

• Primary Device ID: 00190707005764
• NIH Device Record Key: 6e843b48-ec8e-4fc0-8df5-3253ab676b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carriere
• Version Model Number: 424-827C
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707005764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160720

FDA Product Code

• DYW: BRACKET, PLASTIC, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-08

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• 00190707046125: .019 x .025 M-Series Cu Nitanium® 35° D-LX with EZ Stops, Single Pack
• 00190707046118: .020 x .020 M-Series Cu Nitanium® 35° D-LX with EZ Stops, Single Pack
• 00190707046101: .018 M-Series Cu Nitanium® 27° D-LX with EZ Stops, Single Pack
• 00190707046095: .015 M-Series Cu Nitanium® 27° D-LX with EZ Stops, Single Pack
• 00190707037680: Carriere® MOTION 3D Sidekick™ Bondable Hook
• 00190707032920: Carriere® MOTION 3D™ COLORS Class II 27mm-Multi
• 00190707032913: Carriere® MOTION 3D™ COLORS Class II 27mm-Multi
• 00190707032906: Carriere® MOTION 3D™ COLORS Class II 27mm-Multi
• 00190707032890: Carriere® MOTION 3D™ COLORS Class II 25mm-Multi
• 00190707032883: Carriere® MOTION 3D™ COLORS Class II 25mm-Multi
• 00190707032876: Carriere® MOTION 3D™ COLORS Class II 25mm-Multi
• 00190707032869: Carriere® MOTION 3D™ COLORS Class II 23mm-Multi
• 00190707032852: Carriere® MOTION 3D™ COLORS Class II 23mm-Multi
• 00190707032845: Carriere® MOTION 3D™ COLORS Class II 23mm-Multi
• 00190707032838: Carriere® MOTION 3D™ COLORS Class II 20mm-Multi
• 00190707032821: Carriere® MOTION 3D™ COLORS Class II 20mm-Multi
• 00190707032814: Carriere® MOTION 3D™ COLORS Class II 20mm-Multi
• 00190707032807: Carriere® MOTION 3D™ COLORS Class II 18mm-Multi
• 00190707032791: Carriere® MOTION 3D™ COLORS Class II 18mm-Multi
• 00190707032784: Carriere® MOTION 3D™ COLORS Class II 18mm-Multi
• 00190707032777: Carriere® MOTION 3D™ COLORS Class II 16mm-Multi
• 00190707032760: Carriere® MOTION 3D™ COLORS Class II 16mm-Multi
• 00190707032753: Carriere® MOTION 3D™ COLORS Class II 16mm-Multi
• 00190707032746: Carriere® MOTION 3D™ COLORS Class II 27mm-Gold
• 00190707032739: Carriere® MOTION 3D™ COLORS Class II 27mm-Gold
• 00190707032722: Carriere® MOTION 3D™ COLORS Class II 27mm-Gold
• 00190707032715: Carriere® MOTION 3D™ COLORS Class II 25mm-Gold
• 00190707032708: Carriere® MOTION 3D™ COLORS Class II 25mm-Gold
• 00190707032692: Carriere® MOTION 3D™ COLORS Class II 25mm-Gold
• 00190707032685: Carriere® MOTION 3D™ COLORS Class II 23mm-Gold
• 00190707032678: Carriere® MOTION 3D™ COLORS Class II 23mm-Gold
• 00190707032661: Carriere® MOTION 3D™ COLORS Class II 23mm-Gold
• 00190707032654: Carriere® MOTION 3D™ COLORS Class II 20mm-Gold
• 00190707032647: Carriere® MOTION 3D™ COLORS Class II 20mm-Gold
• 00190707032630: Carriere® MOTION 3D™ COLORS Class II 20mm-Gold
• 00190707032623: Carriere® MOTION 3D™ COLORS Class II 18mm-Gold
• 00190707032616: Carriere® MOTION 3D™ COLORS Class II 18mm-Gold
• 00190707032609: Carriere® MOTION 3D™ COLORS Class II 18mm-Gold
• 00190707032593: Carriere® MOTION 3D™ COLORS Class II 16mm-Gold
• 00190707032586: Carriere® MOTION 3D™ COLORS Class II 16mm-Gold
• 00190707032579: Carriere® MOTION 3D™ COLORS Class II 16mm-Gold
• 00190707032562: Carriere® MOTION 3D™ COLORS Class II 27mm-Purple
• 00190707032555: Carriere® MOTION 3D™ COLORS Class II 27mm-Purple
• 00190707032548: Carriere® MOTION 3D™ COLORS Class II 27mm-Purple
• 00190707032531: Carriere® MOTION 3D™ COLORS Class II 25mm-Purple
• 00190707032524: Carriere® MOTION 3D™ COLORS Class II 25mm-Purple
• 00190707032517: Carriere® MOTION 3D™ COLORS Class II 25mm-Purple
• 00190707032500: Carriere® MOTION 3D™ COLORS Class II 23mm-Purple