AURORA Evacuator +Coag

Basic Information

• Brand Name: AURORA Evacuator +Coag
• Primary DI: 00850002332223
• Version / Model: AEC12F/70
• Catalog Number: AEC12F/70
• Company Name: REBOUND THERAPEUTICS CORPORATION
• Labeler DUNS: 080909607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-12
• Public Version: 5
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: f7a3f812-da93-4477-bf79-8ee5f08bb3e8

Device Description

The AURORA® Evacuator +Coag (AEC) is provided sterile, for single use only. It is a handheld, battery powered instrument that combines the ability to aspirate and break up soft tissue and fluids, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site, during minimally invasive surgical procedures.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63649	General-purpose surgical suction system, vacuum	An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.	No	Active
61872	Endoscopic electrosurgical electrode, bipolar, single-use	An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850002332223	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201637	000

Device Sizes

Type	Value	Unit	Text
Length	70	Millimeter