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Prelude SNAP™ 10884450489557

by Merit Medical Systems, Inc.

Ref PLSX-1006/AModel Prelude SNAP™

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

CE MDD

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450489550 Basic UDI-DI 00884450489550UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450489550 UDI-DI Date4 Nov 2020ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Prelude SNAP™
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
Prelude SNAP™, PLSX-1006/A, 10884450489557
Primary DI / UDI-DI
00884450489550 EUDAMED
10884450489557 GUDID
Basic UDI-DI
B-00884450489550
FDA Product Code
DYB
EMDN Code
C0503 Cardiovascular introducer sheaths, peel-away
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1340
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Prelude SNAP™
PLSX-1006/A
GUDID
10884450489557
Primary DI / UDI-DIEUDAMED
00884450489550
GUDID
10884450489557
Device ClassEUDAMED
Class III
GUDID
Class II

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Properties

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

Other properties (16)

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