Penumbra Coil 400

Basic Information

• Brand Name: Penumbra Coil 400
• Primary DI: 00814548018485
• Version / Model: 4004C0615-A
• Catalog Number: 4004C0615
• Company Name: PENUMBRA, INC.
• Labeler DUNS: 191077671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-15
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 3c787efc-8597-40b9-8668-e4b4452f13cd

Device Description

Coil 400 Soft, 6x15

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• 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
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION	Neurology	882.5950	2
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	870.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43980	Embolization implant kit	A collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically consist of, e.g., an embolization implant, an inserter, a dedicated syringe, and possibly other supplies necessary for the surgical procedure. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814548018485	GS1

Premarket Submissions

Submission Number	Supplement Number
K173614	000