ROMEO 2 MIS INSTRUMENTATION MIS-IN 33 01-N

GUDID 07640139349538

Screwdriver shaft PS cannulated

SpineArt SA

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 07640139349538
• NIH Device Record Key: 0b58ce28-76f1-41b2-8f98-cd90109bb03b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 MIS INSTRUMENTATION
• Version Model Number: MIS-IN 33 01-N
• Catalog Number: MIS-IN 33 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	07640139349538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111127

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

[07640139349538]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-05
• Device Publish Date: 2016-09-27

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