AART Nasal Implant

Basic Information

• Brand Name: AART Nasal Implant
• Primary DI: B490402202B0
• Version / Model: B
• Catalog Number: 402-202B
• Company Name: Aart
• Labeler DUNS: 091356894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 77cc4e51-dda1-4c3f-88a9-7266ee90f8cc

Device Description

Nasal Sty 2 Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZE	PROSTHESIS, NOSE, INTERNAL	General, Plastic Surgery	878.3680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31038	Nasal implant, synthetic polymer, non-bioabsorbable	A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B490402202B0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021418	000