OSSEOUS Thermoplastic Splint Kit

Basic Information

• Brand Name: OSSEOUS Thermoplastic Splint Kit
• Primary DI: 08906039316506
• Version / Model: E5150K
• Company Name: EON MEDITECH PRIVATE LIMITED
• Labeler DUNS: 930270428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-04
• Public Version: 1
• Public Version Date: 2024-07-12
• Public Version Status: New
• Public Device Record Key: 0e104065-e904-4339-abd5-e44231fed2a6

Device Description

External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal Septal structure.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
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
Package	08904461000963	GS1	Laminated Box	1	In Commercial Distribution
Primary	08906039316506	GS1
Package	08904428745302	GS1	Laminated Box	10	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius