CEMEX GENTA SYSTEM FAST 70G

GUDID 28031497000538

Cemex Genta System Fast 70g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 70g holds the powder (70g) and liquid

TECRES SPA

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 28031497000538
• NIH Device Record Key: c9d2a055-a5d8-4de6-b90b-0a21beaddff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEMEX GENTA SYSTEM FAST 70G
• Version Model Number: 13A2101 US
• 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: true
• 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	28031497000538 [Primary]

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-07

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