Penumbra System

Basic Information

• Brand Name: Penumbra System
• Primary DI: 00815948020030
• Version / Model: PMXENGN
• Company Name: PENUMBRA, INC.
• Labeler DUNS: 191077671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 2
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 0db6e18d-c643-4049-9a1d-6adbf9a01d65

Device Description

Penumbra ENGINE

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRY	Catheter, Thrombus Retriever	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16779	Suction/irrigation tubing, single-use	A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815948020030	GS1

Premarket Submissions

Submission Number	Supplement Number
K180008	000