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Autopilot Trajectory Guides

by Medtronic Navigation Inc. EUDAMEDGUDID 3 variants

Active European Union

Ref 9736678

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00033868N Basic UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00199150054497 UDI-DIDate11 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Stealth AXiS
Stealth AXiS Autopilot Trajectory Guide 10.5mm
Generic Name
Multi-purpose stereotactic surgery system
Device Name
Autopilot Trajectory Guides
Model / Reference
9736678
Primary DI / UDI-DI
00199150054497, 00763000983840
Basic UDI-DI
0763000B00033868N
510(k) Number
FDA Product Code
OLO
EMDN Code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN Term
Multi-purpose stereotactic surgery system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000023263
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic Navigation, Inc.

See all devices from Medtronic Navigation, Inc. →

Properties

  • Serial Number

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: 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