Carriere® SLX 3D™ Clear

GUDID 00190707061869

Carriere® SLX 3D™ Clear .022 Kit U5x5 HKS

ORTHO ORGANIZERS, INC.

Self-ligating orthodontic bracket

• Primary Device ID: 00190707061869
• NIH Device Record Key: 3245518f-7b98-4e2e-97e1-7f400e0ffaef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carriere® SLX 3D™ Clear
• Version Model Number: 776-KITU-HKS
• 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	00190707061869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173440

FDA Product Code

• NJM: Bracket, ceramic, orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

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