Shikani Antrostomy Stent

Basic Information

• Brand Name: Shikani Antrostomy Stent
• Primary DI: 00385640000185
• Version / Model: SP-80020
• Catalog Number: SP-80020
• Company Name: Summit Medical, Inc.
• Labeler DUNS: 965484699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 8
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 6257d2ac-61ee-49f4-b1c9-2832f3740398

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: Yes
• 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
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	874.4780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61611	Nasal cavity stent, removable, prefabricated	A prefabricated (non-customized) tubular device designed to be temporarily placed in the nasal cavity to improve nasal patency, typically in cases of collapse, hyperplasia or post-operatively. It consists of a self-expanding mesh structure made of metal [e.g., nickel-titanium alloy (Nitinol)], and is intended to be introduced by a healthcare professional or self-introduced; devices associated with insertion and cleaning of the device may be included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385640000185	GS1
Package	10385640000182	GS1	Box	6	In Commercial Distribution

Customer Contacts

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