OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSAL

GUDID 00810131881153

SURGENTEC, LLC

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00810131881153
• NIH Device Record Key: 6c657c06-b40a-4cb4-8255-d2f087aff829
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSAL
• Version Model Number: ONP-T-1000-IB
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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	00810131881153 [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: 2025-06-18
• Device Publish Date: 2025-06-10

On-Brand Devices [ OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSAL]

• 00810131881160: ONP-T-1000-IB
• 00810131881153: ONP-T-1000-IB