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0406850200

by Stryker Corp.

Ref 0406-850-200Model 08858250000009R5

0406850200 (0406-850-200) is a device classified as Class I in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI 08858250000009R5) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04546540904898), active as of 25 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000009R5 Basic UDI-DI 04546540904898UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540904898 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000009R5 registered 24 Jun 2026 Active
  • FDA GUDID UDI-DI 04546540904898 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540904898
  2. Registered EUDAMED 08858250000009R5

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  • Withdrawn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

Generic name
Percutaneous radio-frequency ablation system generator
Device name
RF Cables
Model / Ref / Catalog
08858250000009R5, 0406-850-200, 0406850200
Primary DI / UDI-DI
04546540904898
Basic UDI-DI
08858250000009R5
Direct marketing DI
04546540904898
FDA product code
GXI
EMDN code
Z12010980 Electrosurgery instruments - hardware accessories
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4725
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858250000009R5
0406-850-200
GUDID
0406850200
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Percutaneous radio-frequency ablation system generator

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)