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470015

by Intuitive Surgical, Inc.

Ref 470015

470015 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 26 Oct 2026 (Basic UDI-DI 08868741200887W) and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 00886874112199), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741200887W Basic UDI-DI 00886874112199UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874112199 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741200887W registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874112199 listed 8 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874112199
  2. Registered EUDAMED 08868741200887W

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  • Withdrawn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 Arm Drape
Generic name
Medical equipment/instrument drape, single-use
Device name
Sterile Drapes
Model / reference
470015
Primary DI / UDI-DI
00886874112199
Basic UDI-DI
08868741200887W
FDA product code
NAY, PUI
EMDN code
T020102 Specialistic surgery drapes
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500, 878.4370
EU registration type
Standard device
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

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: Medical equipment/instrument drape, single-use

Similar devices in this category

Other devices filed under SPECIALISTIC SURGERY DRAPES.

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)