ENT Sinus

Basic Information

• Brand Name: ENT Sinus
• Primary DI: 00817470009750
• Version / Model: 602-00210S
• Catalog Number: 602-00210S
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 8
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 7f53136c-15bc-4db1-bdd3-446a794ee530
• Distribution End Date: 2022-03-17

Device Description

MediENT Middle Turbinate Implant 1-pack

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: 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
41493	Intranasal splint, biodegradable	A bioabsorbable device intended to be placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made of non-animal source material which chemically degrades after about 3 – 4 weeks and is absorbed via natural body processes, or it may be removed at the discretion of the physician. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817470009750	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130354	000