BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc ABS-3101

GUDID 00812337020435

Fast-Setting Drillable Calcium Phosphate Cement

DSM BIOMEDICAL, INC.

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• Primary Device ID: 00812337020435
• NIH Device Record Key: de8ad084-89d2-4714-ab07-a2fe84255612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc
• Version Model Number: 21003-04
• Catalog Number: ABS-3101
• Company DUNS: 131107757
• Company Name: DSM BIOMEDICAL, INC.
• 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	00812337020435 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2023-05-17
• Device Publish Date: 2023-05-09

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