Arthrex Bone Cement HV w/G

GUDID 08058964728722

G21 SRL

Orthopaedic cement, antimicrobial

• Primary Device ID: 08058964728722
• NIH Device Record Key: 06a911c3-3198-45a8-8d6f-5279acc67149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex Bone Cement HV w/G
• Version Model Number: AR-901-HVG
• Company DUNS: 431529195
• Company Name: G21 SRL
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058964728722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173494

FDA Product Code

• LOD: Bone Cement

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: 2024-09-24
• Device Publish Date: 2024-09-16

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