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SureForm 48345G

by Intuitive Surgical, Inc.

Part of a family of 13 devices: see the family page

Ref 48345G

SureForm 48345G is a device classified as Class IIb in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 08868741200717D) and listed in FDA GUDID since 15 Mar 2019 (UDI-DI 00886874117095), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741200717D Basic UDI-DI 00886874117095UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874117095 UDI-DI Date15 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08868741200717D registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00886874117095 listed 15 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886874117095
  2. Registered EUDAMED 08868741200717D

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  • Withdrawn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 45 Reload, Green EUDAMED
SureForm GUDID
Generic name
Surgical staple loading unit, non-cutting
Device name
Stapler Reloads
Model / reference
48345G
Primary DI / UDI-DI
00886874117095
Basic UDI-DI
08868741200717D
FDA product code
GDW, NAY
EMDN code
H02030106 Linear stapler cartridges for videosurgery
GMDN term
Surgical staple loading unit, non-cutting
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4750, 876.1500
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Depth — 4.3 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Surgical staple loading unit, non-cutting

Similar devices in this category

Other devices filed under LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

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