Skip to content

VisionAir 3D Stent 0010-0126

by Custom Orthopaedic Solutions, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00811813020525 UDI-DI Date11 Mar 2024ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
VisionAir 3D Stent
Generic Name
Polymeric tracheal/bronchial stent, non-bioabsorbable
Model / Reference
0010-0126
Primary DI / UDI-DI
00811813020525
FDA Product Code
NWA
GMDN Term
Polymeric tracheal/bronchial stent, non-bioabsorbable
Device Class
Class II
Regulation Number
878.3720
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Other devices from Custom Orthopaedic Solutions, Inc.

See all devices from Custom Orthopaedic Solutions, Inc. →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No