TurbAlign

Basic Information

• Brand Name: TurbAlign
• Primary DI: 00860011696339
• Version / Model: FG-0019
• Company Name: SPIRAIR, INC.
• Labeler DUNS: 111289449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-02
• Public Version: 1
• Public Version Date: 2025-09-10
• Public Version Status: New
• Public Device Record Key: 92ab1630-db62-460d-a841-5a20b2015ce5

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	00860011696339	GS1

Premarket Submissions

Submission Number	Supplement Number
K243655	000