Arthrex Bone Cement MV

GUDID 08058964728739

G21 SRL

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 08058964728739
• NIH Device Record Key: dffe626b-ea73-4c44-a3e0-5c6d29f3b1b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex Bone Cement MV
• Version Model Number: AR-901-MV
• 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	08058964728739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193061

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 MV]

• 08058964728739: AR-901-MV
• 08058964729040: AS-901-MV