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40006 PercuNav Coaxial Needle Tracker, 18Gx13cm

by Philips Ultrasound LLC

Ref 989605428034

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM435SZ Basic UDI-DI 00884838083028UDI-DIDate7 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838083028 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
40006 PercuNav Coaxial Needle Tracker, 18Gx13cm EUDAMED
40006 PercuNav Coaxial Needle Tracker, 18G x 13 cm GUDID
Generic Name
Multi-purpose stereotactic surgery system
Device Name
Philips PercuNav Coaxial Needle Tracker
Model / Reference
989605428034
Primary DI / UDI-DI
00884838083028
Basic UDI-DI
0884838BM435SZ
FDA Product Code
LLZ, IYO, JAK
EMDN Code
Z12011485 Surgical navigation instruments - consumables
GMDN Term
Multi-purpose stereotactic surgery system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050, 892.1560, 892.1750
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-MF-000002237
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

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Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (19)

  • 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
  • Manufacturing Date: No