AMstent Tracheobronchial Covered Stent System

Basic Information

• Brand Name: AMstent Tracheobronchial Covered Stent System
• Primary DI: 00860001217001
• Version / Model: AMS1040
• Catalog Number: AMS1040
• Company Name: Peytant Solutions, Inc.
• Labeler DUNS: 808218015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 1
• Public Version Date: 2025-12-29
• Public Version Status: New
• Public Device Record Key: ddee2c73-b0c9-4761-a49e-c7e9cb6457b1

Device Description

The AMStent® Tracheobronchial Covered Stent System (AMStent System) is a tracheal prothesis with cover material derived from human sources. The AMStent System is a single use tracheobronchial prosthesis used to establish patency of the tracheobronchial tree. The AMStent System components include the implantable AMStent preloaded on a single-use AMStent delivery catheter. The AMStent System contains tissue contacting components, implantable components, and is provided sterile for single use in a professional healthcare facility. There are no electrical components, and the AMStent System is not intended to be marketed with multiple system / kit components or accessories.

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
SDB	Tracheal Prosthesis With Cover Material Derived From Human Sources	Anesthesiology	868.3721	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67641	Human-derived tracheal/bronchial stent	A non-bioabsorbable tubular device, which includes human-derived materials, intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency, to treat tracheobronchial strictures (e.g., produced by malignant neoplasms). It is in the form of a metal mesh covered by a decellularized human-derived membrane, and is typically expandable in situ (e.g., with a balloon catheter or self-expandable); disposable devices intended to assist implantation may be included with the stent.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001217001	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN230087	000