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430012

by Intuitive Surgical, Inc.

Ref 430012

430012 is a device classified as Class IIa in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 08868741200577K) and listed in FDA GUDID since 20 Sep 2018 (UDI-DI 00886874114346), 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 Number08868741200577K Basic UDI-DI 00886874114346UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874114346 UDI-DI Date20 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741200577K registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874114346 listed 20 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874114346
  2. Registered EUDAMED 08868741200577K

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  • Withdrawn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
Instrument Sheath
Generic name
Optical medical device procedural cover
Device name
Tip cover accessory & Instrument Sheaths
Model / reference
430012
Primary DI / UDI-DI
00886874114346 EUDAMED
10886874114343 GUDID
Basic UDI-DI
08868741200577K
FDA product code
NAY
EMDN code
Z12029085 Various instruments for endoscopy and mini-invasive surgery - consumables
GMDN term
Optical medical device procedural cover
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00886874114346
GUDID
10886874114343
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00886874114346; FDA GUDID lists 10886874114343), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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: Optical medical device procedural cover

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)