ROMEO 2 MIS INSTRUMENTATION NAV-IN 10 01-N

GUDID 07640185341395

Nav. Screwdriver, SS

SpineArt SA

Surgical screwdriver, reusable

• Primary Device ID: 07640185341395
• NIH Device Record Key: f9e79872-b0fa-472a-b45e-4f100886b406
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 MIS INSTRUMENTATION
• Version Model Number: NAV-IN 10 01-N
• Catalog Number: NAV-IN 10 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	07640185341395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183630

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

[07640185341395]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [ROMEO 2 MIS INSTRUMENTATION]

• 07640139349538: Screwdriver shaft PS cannulated
• 07640185341395: Nav. Screwdriver, SS
• 07640185341388: Nav. Screwdriver, PS Cannulated
• 07640185341371: Cannulated Nav. Tap
• 07640185341364: Cannulated Nav. Tap
• 07640185341357: Cannulated Nav. Tap
• 07640185341340: Cannulated Nav. Tap