ROMEO 2 INSTRUMENTATION DEGEN NAV-IN 10 40-N

GUDID 07640185341333

Nav. Tap

SpineArt SA

Bone tap, reusable

• Primary Device ID: 07640185341333
• NIH Device Record Key: 964557c0-8608-463d-a41f-e95001f204f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 INSTRUMENTATION DEGEN
• Version Model Number: NAV-IN 10 40-N
• Catalog Number: NAV-IN 10 40-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 Dimensions

• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640185341333 [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

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

Moist Heat or Steam Sterilization

[07640185341333]

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

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