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RONDO' Box for ø7.5mm screws

by Citieffe

Part of a family of 19 devices: see the family page

Ref VT-96310Model Box

RONDO' Box for ø7.5mm screws (VT-96310) is a device classified as Class I in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI 803290962155C7), cleared under FDA 510(k) K113388 on 5 Jun 2012 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 08032909627165), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113388

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962155C7 Basic UDI-DI 08032909627165UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909627165 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113388 Date5 Jun 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962155C7 registered 16 Sep 2026 Active
  • FDA 510(k) K113388 decided 5 Jun 2012 Active
  • FDA GUDID UDI-DI 08032909627165 listed 26 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113388
  2. Listed FDA GUDID 08032909627165
  3. Registered EUDAMED 803290962155C7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Surgical Instruments (I) EUDAMED
Rondo' GUDID
Generic name
Pass-through cabinet
Model / Ref / Catalog
Box, VT-96310, Box for ø7.5mm screws
Primary DI / UDI-DI
08032909627165
Basic UDI-DI
803290962155C7
Direct marketing DI
08032909627165
510(k) Number
FDA product code
HTY, HTN, HWC
EMDN code
V0499 Clinical use containers (non-IVD) - other
GMDN term
Pass-through cabinet
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Box
VT-96310
GUDID
Box for ø7.5mm screws
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08032909627165: EUDAMED states Yes, FDA GUDID states No.

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: Pass-through cabinet

Cleared under the same submission (K113388)

and 8 more cleared under K113388

Similar devices

Also classified as Pass-through cabinet.

Similar devices in this category

Other devices filed under CLINICAL USE CONTAINERS (NON-IVD) - OTHER.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)