Thermoplastic Nasal Splints

Basic Information

• Brand Name: Thermoplastic Nasal Splints
• Primary DI: 10841962118702
• Version / Model: THERM
• Catalog Number: THERM
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-12-20
• Public Version: 2
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 3df3f428-114c-4dc4-a795-6cf45ee8797f

Device Description

Cosmetic Surgery Suppliers, Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EPP	SPLINT, NASAL	Ear, Nose, Throat	874.5800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35411	External nasal splint	A rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10841962118719	GS1
Primary	10841962118702	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	.063	Inch