Bone Cement - Normal Viscosity 2005-00-000

GUDID 07898315500901

https://www.biomecanica.com.br/instrucoes-de-uso/

Biomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 07898315500901
• NIH Device Record Key: 1a15dc20-c12d-43d1-8d3d-c21affaa35f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Cement - Normal Viscosity
• Version Model Number: Bone Cement - Normal Viscosity
• Catalog Number: 2005-00-000
• Company DUNS: 898947379
• Company Name: Biomecânica Indústria e Comércio de Produtos Ortopédicos 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07898315500901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212729

FDA Product Code

• LOD: Bone Cement

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23