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Oral Surgery Set 12.S4096.00

by Omnia Spa EUDAMEDGUDID

Active European Union

Ref 12.S4096.00

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08056646500321 Basic UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056646500321 UDI-DIDate27 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Oral Surgery Set
Generic Name
General surgical procedure kit, non-medicated, single-use
Device Name
Custom Packs for Diagnosis and Surgery
Model / Reference
12.S4096.00
Primary DI / UDI-DI
08056646500321
Basic UDI-DI
B-08056646500321
510(k) Number
FDA Product Code
KKX
EMDN Code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
GMDN Term
General surgical procedure kit, non-medicated, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4370
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K110724)

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Other devices from Omnia Spa

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No