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Guidewire Introducer Needles

by Argon Medical Devices, Inc. EUDAMEDGUDID

Active European Union

Ref MPCN1802, 395536, 395200Model 395536, 395200, 395513, 395451, 395770, 395206

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-20886333002881 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-20886333002881 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333002881 UDI-DIDate12 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, 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

1 recall · FDA

    • Terminated Z-2018-2010 FDA Unclassified (pre-2012) initiated 1 Sep 2009

    Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.

Specification

EUDAMED · GUDID

Trade Name
Guidewire Introducer Needles EUDAMED
Guidewire EUDAMEDGUDID
Modified Potts/Cournand Needle GUDID
Generic Name
Peripheral vascular guidewire, manual
Needle guide, single-use
Model / Ref / Catalog
MPCN1802, 395200, 395536, 395513, 395451, 395770, 395206
Primary DI / UDI-DI
20886333002881 EUDAMED
10886333211651 EUDAMED
10886333210944 EUDAMED
00886333210947 GUDID
00886333211654 GUDID
00886333002887 GUDID
Basic UDI-DI
B-20886333002881, 08863332700022E
Unit of Use DI
00886333211654, 00886333210947
510(k) Number
FDA Product Code
DQX, DRC
EMDN Code
C0501, C058099, A060299, C04020102
GMDN Term
Peripheral vascular guidewire, manual
Needle guide, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1330, 870.1390
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20886333002881
10886333211651
10886333210944
GUDID
00886333210947
00886333211654
00886333002887
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002324
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No