SurgiPlast Nasal Splint

Basic Information

• Brand Name: SurgiPlast Nasal Splint
• Primary DI: 00854804007129
• Version / Model: SurgiPlast - Large - Skin Color - 1.6mm
• Company Name: SURGICAL TECHNOLOGY LABORATORIES INC
• Labeler DUNS: 080380106
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-30
• Public Version: 1
• Public Version Date: 2024-10-08
• Public Version Status: New
• Public Device Record Key: 11bb7cbf-9084-4e98-b7ee-ef01048de6b0

Device Description

SurgiPlast - Large - Skin Color - 1.6mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
Primary	00854804007129	GS1