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470395

by Intuitive Surgical, Inc.

Ref 470395

470395 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 28 Aug 2026 (Basic UDI-DI 08868741210547L) and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 00886874112632), 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 Number08868741210547L Basic UDI-DI 00886874112632UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874112632 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741210547L registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874112632 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874112632
  2. Registered EUDAMED 08868741210547L

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  • Withdrawn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
12 mm & Stapler Bladeless Obturator
Generic name
Laparoscopic trocar blade, reusable
Device name
Obturators
Model / reference
470395
Primary DI / UDI-DI
00886874112632
Basic UDI-DI
08868741210547L
Direct marketing DI
00886874112632
FDA product code
NAY, GCJ
EMDN code
L1399 Robotic surgery instruments, reusable - other
GMDN term
Laparoscopic trocar blade, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 12 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Laparoscopic trocar blade, reusable

Similar devices in this category

Other devices filed under ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)