Aquaplast PS™

Basic Information

• Brand Name: Aquaplast PS™
• Primary DI: 00841962120319
• Version / Model: PS-1309CSS
• Catalog Number: PS-1309CSS
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-09
• Public Version: 1
• Public Version Date: 2025-07-17
• Public Version Status: New
• Public Device Record Key: 0b04f9a8-b150-4d5a-a13e-2683fdfdf528

Device Description

Blush, 1/16", Trapezoidal Splint, pkg. of 10 - CSS

Device Characteristics

• Single Use: No
• 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: No
• 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
Primary	00841962120319	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K942158	000