Apollo System

Basic Information

• Brand Name: Apollo System
• Primary DI: 00814548016344
• Version / Model: AP9-A
• Company Name: PENUMBRA, INC.
• Labeler DUNS: 191077671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-03
• Public Version: 1
• Public Version Date: 2019-02-04
• Public Version Status: New
• Public Device Record Key: a07c3751-acf8-4ae0-b971-d435e27466ea

Device Description

Apollo Wand, Long

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: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWG	Endoscope, Neurological	Neurology	882.1480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41978	Surgical irrigation/aspiration system	An assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814548016344	GS1

Premarket Submissions

Submission Number	Supplement Number
K132931	000