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470042

by Intuitive Surgical, Inc.

Ref 470042

470042 is a device classified as Class I in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 08868741201947W) and listed in FDA GUDID since 26 Aug 2019 (UDI-DI 00886874115732), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741201947W Basic UDI-DI 00886874115732UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874115732 UDI-DI Date26 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741201947W registered 4 Jun 2026 Active
  • FDA GUDID UDI-DI 00886874115732 listed 26 Aug 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874115732
  2. Registered EUDAMED 08868741201947W

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  • Withdrawn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
Handheld Camera Light Guide
Generic name
Fibreoptic light cable, reusable
Device name
Light Guide
Model / reference
470042
Primary DI / UDI-DI
00886874115732
Basic UDI-DI
08868741201947W
Direct marketing DI
00886874115732
FDA product code
GCJ
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Fibreoptic light cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00886874115732: EUDAMED states No, FDA GUDID states Yes.

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: Fibreoptic light cable

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)