Arthrex Bone Cement HV

GUDID 08058964728647

G21 SRL

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 08058964728647
• NIH Device Record Key: c6cdb8ca-8c05-4469-a26f-2bac37bfafdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex Bone Cement HV
• Version Model Number: AR-901-HV
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058964728647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193059

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

On-Brand Devices [Arthrex Bone Cement HV]

• 08058964728647: AR-901-HV
• 08058964729033: AS-901-HV