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Synchro2 S2SPP14215

by Stryker Corp.

Ref S2SPP14215Model 08858250000271RL

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

CE MDR

Valid until

14 Oct 2027

CE MDR certificate

FDA recalls

None ongoing

8 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000271RL Basic UDI-DI 07613327459654UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327459654 UDI-DI Date20 Jun 2019ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 736168 Expiring Supplemented Expires in 346 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    23 Dec 2023
    Expires
    14 Oct 2027
    Reason
    Other

Recalls

8 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0230-2020 FDA Class II initiated 8 Jun 2018
    • Terminated Z-0229-2020 FDA Class II initiated 8 Jun 2018
    • Terminated Z-0226-2020 FDA Class II initiated 8 Jun 2018
    • Terminated Z-0231-2020 FDA Class II initiated 8 Jun 2018
    • Terminated Z-0232-2020 FDA Class II initiated 8 Jun 2018
    • Terminated Z-0225-2020 FDA Class II initiated 8 Jun 2018
    • Terminated Z-0228-2020 FDA Class II initiated 8 Jun 2018

    The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

    • Terminated Z-0227-2020 FDA Class II initiated 8 Jun 2018

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Synchro2
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Device Name
Synchro2 Guidewire Series
Model / Ref / Catalog
S2SPP14215, 08858250000271RL
Primary DI / UDI-DI
07613327459654
Basic UDI-DI
08858250000271RL
FDA Product Code
DQX, MOF
EMDN Code
C0499 Cardiovascular guidewires - other
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1330
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 0.014 Inch
Length — 215.0 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Cardiac/peripheral vascular guidewire, single-use

Cleared under the same submission (K190843)

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

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

Other properties (19)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No