Pulec

Basic Information

• Brand Name: Pulec
• Primary DI: 00681490036115
• Version / Model: 117200
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a267bfb9-c089-4bfc-8644-128db1397f71

Device Description

SHUNT 117200 PULEC ENDOLYMPHATIC C-FLEX

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ESZ	TUBE, SHUNT, ENDOLYMPHATIC	Ear, Nose, Throat	874.3820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16033	Endolymphatic shunt	A sterile tube or sheet surgically implanted in the membranous labyrinth of the inner ear to drain excess endolymphatic fluid typically as treatment for Meniere's disease, an inner ear disorder. The device permits unrestricted flow of the fluid from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. It is typically made of silicone. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00681490036115	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K834094	000

Device Sizes

Type	Value	Unit	Text
Length	18.5	Millimeter