CEMEX XL

GUDID 28031497000057

Cemex XL is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (50g powder and 18.33g liquid) which are designed fo

TECRES SPA

Orthopaedic cement, non-medicated

• Primary Device ID: 28031497000057
• NIH Device Record Key: 100e81b4-3fb1-4baf-940e-7c1f86f70551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEMEX XL
• Version Model Number: 1200/S
• Company DUNS: 435428396
• Company Name: TECRES SPA
• 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: false
• 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	28031497000057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021715

FDA Product Code

• LOD: Bone Cement

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-08
• Device Publish Date: 2015-10-08

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