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Alcon, Intrepid 8065751922

by Alcon Laboratories, Inc.

Ref 8065751922, 8065750515, 8065751512, 8065752145, 8065750517

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000176HH Basic UDI-DI Date6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380657519224 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
Intrepid EUDAMED
Alcon, Intrepid GUDID
Infinit, Microsmooth, Alcon GUDID
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Name
Intrepid 0.3mm Polymer I/A Hand Piece
Small Parts Kit (Sterile)
Intrepid 0.3 Polymer I/A Tips
Model / Reference
8065751922, 8065750517, 8065752145, 8065750515, 8065751512
Primary DI / UDI-DI
00380657519224, 00380657505173, 00380657521456, 00380657505159, 00380657515127
Basic UDI-DI
038065GMN000176HH, 038065GMN000197HR, 038065GMN000175HF
FDA Product Code
HQC
EMDN Code
Z1212020785 Phaco-vitrectomy instruments - consumables
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.4670
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 0.9 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No