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Silhouette® Peel-Away®

by Cook Incorporated 14 variants

Ref PLVTW-17.0-38-15.5

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002282322 Basic UDI-DI 00827002282322UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002282322 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Silhouette® Peel-Away® EUDAMED
Silhouette GUDID
Generic Name
Non-vascular catheter introduction set
Model / Ref / Catalog
PLVTW-17.0-38-15.5, G28232
Primary DI / UDI-DI
00827002282322
Basic UDI-DI
B-00827002282322
FDA Product Code
KGZ
EMDN Code
C0503 Cardiovascular introducer sheaths, peel-away
GMDN Term
Non-vascular catheter introduction set
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4200
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PLVTW-17.0-38-15.5
GUDID
G28232
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000003180
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

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

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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