CEMEX ISOPLASTIC 1/2 PACK

GUDID 28031497000071

Cemex Isoplastic 1/2 pack is a high viscosity polymethylmethacrylate bone cement. It is composed by two components (20g powder and 6.65g liquid) whic

TECRES SPA

Orthopaedic cement, non-medicated

• Primary Device ID: 28031497000071
• NIH Device Record Key: b02a890b-e0e2-4880-9592-db530bfa1c57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEMEX ISOPLASTIC 1/2 PACK
• Version Model Number: 1220/I
• 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	28031497000071 [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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