ALAR®

Basic Information

• Brand Name: ALAR®
• Primary DI: 00763000038182
• Version / Model: 15000
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-15
• Public Version: 1
• Public Version Date: 2020-10-23
• Public Version Status: New
• Public Device Record Key: c508b80a-48d7-46fa-b5ea-fc8cbea98e36

Device Description

STENT 15000 2PK ALAR NASALVALVE COLLAPSE

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
LYA	SPLINT, INTRANASAL SEPTAL	Ear, Nose, Throat	874.4780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62718	Intranasal splinting set	A collection of sterile, non-biodegradable devices intended to temporarily support and immobilize intranasal tissues during the postoperative healing period following intranasal and nasal valve surgery. It consists of a synthetic polymer splint designed to be surgically placed into the nasal cavity, via a nostril, with included suture and needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000038186	GS1	PK	2	In Commercial Distribution
Primary	00763000038182	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151758	000

Device Sizes

Type	Value	Unit	Text
Height	0.5	Millimeter
Width	16.0	Millimeter
Length	19.0	Millimeter