ROMEO 2 MIS MIS-IN 05 01-N

GUDID 07640151082499

DILATOR TUBE 3 PEEK

SpineArt SA

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 07640151082499
• NIH Device Record Key: b51214c4-601f-48b7-a831-d8c2a6e0c7b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 MIS
• Version Model Number: MIS-IN 05 01-N
• Catalog Number: MIS-IN 05 01-N
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	07640151082499 [Primary]

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07640151082499]

Moist Heat or Steam Sterilization

[07640151082499]

Moist Heat or Steam Sterilization

[07640151082499]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

On-Brand Devices [ROMEO 2 MIS]

• 07640178985018: Trocar awl
• 07640178985001: Trocar needle
• 07640178984998: Needle cap
• 07640178984981: Trocar Handle
• 07640151082499: DILATOR TUBE 3 PEEK
• 07640151082482: DILATOR TUBE # 2 PEEK