CERAMIC BRACKET ICERAM ROTH 0.018 - U3L(23) - 1UN

GUDID 07898488902489

CERAMIC BRACKET ICERAM ROTH 0.018 - U3L(23) - 1UN

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic bracket, ceramic

• Primary Device ID: 07898488902489
• NIH Device Record Key: e133b0a2-7929-4df2-9418-908e87c337a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMIC BRACKET ICERAM ROTH 0.018 - U3L(23) - 1UN
• Version Model Number: 10.80.1123
• Company DUNS: 898330003
• Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	07898488902489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222847

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: 2025-12-24
• Device Publish Date: 2025-12-16

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