Easy Cut Splint

Basic Information

• Brand Name: Easy Cut Splint
• Primary DI: 00198715553499
• Version / Model: 2513155
• Company Name: Tacklebox Medical, LLC
• Labeler DUNS: 091289530
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-25
• Public Version: 1
• Public Version Date: 2024-12-03
• Public Version Status: New
• Public Device Record Key: f2a37619-c44f-4d5a-ba73-df20e7959bf3

Device Description

The Easy Cut Intranasal Splint is designed to maintain a nasal airway and provide septal support post-operatively after septal and/or cosmetic nasal surgery. As an added feature, the anterior tip of each splint has an elevated suture channel for suture placement through the splint and septum to prevent posterior dislodgement. The elevated suture channel provides easy access to the suture and aids in suture removal. Each splint has an elevated suture channel on each end so that a splint can be used on the right or left side. The splints are supplied sterile in packages containing two (2) splints. There are five (5) packages in a box.

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: 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
Primary	00198715553499	GS1

Customer Contacts

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