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SureForm 480445

by Intuitive Surgical, Inc.

Ref 480445

SureForm 480445 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 08868741209418H) and listed in FDA GUDID since 15 Mar 2019 (UDI-DI 00886874117583), 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 Number08868741209418H Basic UDI-DI 00886874117583UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874117583 UDI-DI Date15 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741209418H registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874117583 listed 15 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874117583
  2. Registered EUDAMED 08868741209418H

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  • Withdrawn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
SureForm Stapler 45 EUDAMED
SureForm GUDID
Generic name
Robotic surgical cutting stapler, single-use
Device name
SureForm Stapler Instrument
Model / reference
480445
Primary DI / UDI-DI
00886874117583
Basic UDI-DI
08868741209418H
FDA product code
GDW, NAY
EMDN code
H020301050299 Single patient articulated linear staplers without blade for videosurgery – other
GMDN term
Robotic surgical cutting stapler, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4750, 876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 14 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Robotic surgical cutting stapler, single-use

Similar devices

Also classified as Robotic surgical cutting stapler, single-use.

Similar devices in this category

Other devices filed under SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT BLADE FOR VIDEOSURGERY – OTHER.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)