Y-Stent with Tracheal Posts with 1mm Wall Thickness

Basic Information

• Brand Name: Y-Stent with Tracheal Posts with 1mm Wall Thickness
• Primary DI: 00815347024035
• Version / Model: YS1-1613-S
• Company Name: HOOD, E BENSON LABORATORIES INC
• Labeler DUNS: 076603380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-21
• Public Version: 1
• Public Version Date: 2023-11-29
• Public Version Status: New
• Public Device Record Key: 72929cb7-4dcf-4eae-95c5-b41c5a0470a1

Device Description

E. Benson Hood Laboratories Y-Stent

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NWA	Prosthesis, Tracheal, Preformed/Molded	General, Plastic Surgery	878.3720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35404	Tracheostomy tube, non-reinforced, non-customized, single-use	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815347024035	GS1

Premarket Submissions

Submission Number	Supplement Number
K873742	000