ROMEO® 2 ELL-IN 00 42-S

GUDID 07640151088323

CEMENT FILLER PP

SpineArt SA

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• Primary Device ID: 07640151088323
• NIH Device Record Key: 59aade53-32c9-40dd-9947-3392a3128330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO® 2
• Version Model Number: ELL-IN 00 42-S
• Catalog Number: ELL-IN 00 42-S
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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	07640151088323 [Primary]

FDA Product Code

• PML: Bone Cement, Posterior Screw Augmentation

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: 2023-07-05
• Device Publish Date: 2023-06-27

On-Brand Devices [ROMEO® 2]

• 07640185348585: MODULAR SPLIT TIP SETSCREW STARTER
• 07640151088323: CEMENT FILLER PP