PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR

GUDID 07908611211170

PREMIUM ELITE KIT MBT 0.022 1 SET 4 TUBES 1 PAIR OF ARCHWIRES 1 MODULAR LIGATURE

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic tube

• Primary Device ID: 07908611211170
• NIH Device Record Key: 4f7250f2-ee48-4c31-aa1b-ed0916ee3cfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR
• Version Model Number: 11.21.2913
• Company DUNS: 898330003
• Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07908611211170 [Primary]

FDA Product Code

• DZD: Tube, 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: 2025-04-15
• Device Publish Date: 2025-04-07

Devices Manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

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• 07898488902441 - CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM ROTH 0.018 - U2R(12) - 1UN
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• 07908611215536 - CERAMIC BRACKET ICERAM-P ROTH 0.018 - 1 SET: 2025-12-19 CERAMIC BRACKET ICERAM-P ROTH 0.018 - 1 SET
• 07908611215543 - CERAMIC BRACKET ICERAM-P ROTH 0.018 - U1R(11) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM-P ROTH 0.018 - U1R(11) - 1UN
• 07908611215550 - CERAMIC BRACKET ICERAM-P ROTH 0.018 - U2R(12) - 1UN: 2025-12-19 CERAMIC BRACKET ICERAM-P ROTH 0.018 - U2R(12) - 1UN