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MEDRAD® Stellant Sterile Disposable Syringe SSS-QFT

by Bayer Medical Care Inc.

Ref SSS-QFT

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

6 closed

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 Number0616258TFCN-0050Q5 Basic UDI-DI 00616258024646UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258024646 UDI-DI Date6 May 2024ListedStatusListed 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.

Recalls

6 recalls · FDA

    • Terminated Z-0745-2019 FDA Class II initiated 14 Dec 2018

    If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

    • Terminated Z-0147-2012 FDA Unclassified (pre-2012) initiated 24 Oct 2011

    Packaging may exhibit open seals - sterility compromised

    • Terminated Z-1954-2010 FDA Unclassified (pre-2012) initiated 24 May 2010

    Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.

    • Terminated Z-0154-06 FDA Unclassified (pre-2012) initiated 10 Oct 2005

    the heat maintainer, an accessory, may overheat and deform the disposable syringe

    • Terminated Z-0257-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Sterility can be compromised by a tear in the outer packaging.

    • Terminated Z-0039-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004

    Sterility can be compromised by a component tearing the outer packaging

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  • Withdrawn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
MEDRAD® Stellant Syringe Kits EUDAMED
MEDRAD® Stellant Sterile Disposable Syringe GUDID
Generic Name
Angiographic syringe
Model / Ref / Catalog
SSS-QFT
Primary DI / UDI-DI
00616258024646
Basic UDI-DI
0616258TFCN-0050Q5
510(k) Number
FDA Product Code
DXT
EMDN Code
A02010401 Syringes for contrast media injector, single-use
GMDN Term
Angiographic syringe
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
Netherlands
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 (K023183)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No