AURORA Evacuator AURORA Evacuator-10Fx13cm

GUDID 00850002332001

The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures.

REBOUND THERAPEUTICS CORPORATION

General-purpose surgical suction system, vacuum

• Primary Device ID: 00850002332001
• NIH Device Record Key: 14d3ce66-f69c-4182-860e-94696c1900e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURORA Evacuator
• Version Model Number: AURORA Evacuator-10Fx13cm
• Catalog Number: AURORA Evacuator-10Fx13cm
• Company DUNS: 080909607
• Company Name: REBOUND THERAPEUTICS CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850002332001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190075

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-08
• Device Publish Date: 2019-04-30

On-Brand Devices [AURORA Evacuator ]

• 00860624000431: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00860624000424: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00860624000417: The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332087: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332070: The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332063: The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332025: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332018: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332001: The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332162: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332155: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp
• 00850002332148: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, asp