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AMstent Tracheobronchial Covered Stent System AMS1040

by Peytant Solutions, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860001217001 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AMstent Tracheobronchial Covered Stent System
Generic Name
Human-derived tracheal/bronchial stent
Model / Ref / Catalog
AMS1040
Primary DI / UDI-DI
00860001217001
De Novo Number
FDA Product Code
SDB
GMDN Term
Human-derived tracheal/bronchial stent
Device Class
Class II
Regulation Number
868.3721
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Peytant Solutions, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No