Bivalve Internal Nasal Splint

Basic Information

• Brand Name: Bivalve Internal Nasal Splint
• Primary DI: 00818501020935
• Version / Model: 20-10650S
• Catalog Number: 20-10650S
• Company Name: INVOTEC INTERNATIONAL, INC.
• Labeler DUNS: 622812592
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 1
• Public Version Date: 2022-12-14
• Public Version Status: New
• Public Device Record Key: ab28170b-3d37-4294-a71a-10c08b421c2f

Device Description

Bivalve Internal Nasal Splint, Standard, 0.25mm, Singles Fluoroplastic

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
31919	Intranasal splint, non-biodegradable	A non-biodegradable device intended to be temporarily 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 typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818501020932	GS1	Box	10	In Commercial Distribution
Primary	00818501020935	GS1