Skip to content

Compass International SOFTWARE

by Compass International

Compass International SOFTWARE is a Class II device made by Compass International, listed in FDA GUDID since 26 Aug 2016 (UDI-DI B169SOFTWARE0), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB169SOFTWARE0 UDI-DI Date26 Aug 2016ListedStatusListed GUDID: 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  • Withdrawn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
Compass International
Generic name
Stereotactic system application software
Model / Ref / Catalog
SOFTWARE
Primary DI / UDI-DI
B169SOFTWARE0
FDA product code
HAW
GMDN term
Stereotactic system application software
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stereotactic system application software

Other devices from Compass International

See all devices from Compass International →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)