ROMEO ® 2 PAD INSTRUMENTATION PAD-IN 06 00-N

GUDID 07640139349316

Tightener

SpineArt SA

Implant handling forceps, alligator

• Primary Device ID: 07640139349316
• NIH Device Record Key: 84f72f3a-6f6b-4599-8cc0-0d8d5aa1546e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO ® 2 PAD INSTRUMENTATION
• Version Model Number: PAD-IN 06 00-N
• Catalog Number: PAD-IN 06 00-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	07640139349316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141508

FDA Product Code

• PEK: Spinous Process Plate

Sterilization

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

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

[07640139349316]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-31
• Device Publish Date: 2018-07-31

On-Brand Devices [ROMEO ® 2 PAD INSTRUMENTATION]

• 07640151081515: Spreader
• 07640151081508: Curette
• 07640139349316: Tightener
• 07640139349231: Process Preparer