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Ion 490127

by Intuitive Surgical, Inc.

Ref 490127

Ion 490127 is an instrument management bag (EU MDR Class I; FDA Class II; FDA product code PUI, Drape, surgical, exempt) made by Intuitive Surgical, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 088687412269393) and listed in FDA GUDID since 3 Sep 2020 (UDI-DI 00886874119594), 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 Number088687412269393 Basic UDI-DI 00886874119594UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874119594 UDI-DI Date3 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 088687412269393 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00886874119594 listed 3 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874119594
  2. Registered EUDAMED 088687412269393

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  • Withdrawn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
Vision Probe Bag EUDAMED
Ion GUDID
Generic name
Instrument management bag
Device name
Ion Vision Probe Bag
Model / reference
490127
Primary DI / UDI-DI
00886874119594
Basic UDI-DI
088687412269393
FDA product code
PUI
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Instrument management bag
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
EU registration type
Standard device
EU market of registration
Germany
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: Instrument management bag

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)