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Disposable Bipolar Pencil 37mm Tip Length, 25 Gauge Straight

by Kirwan Surgical Products LLC

Ref 14-5011L

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

7 ongoing

This device is named in the recall

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-00841019101056 Basic UDI-DI 00841019101056UDI-DIDate23 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00841019101056 UDI-DI Date17 Apr 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.

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-0658-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0659-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0654-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0656-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0660-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0655-2025 FDA Class I initiated 14 Nov 2024
    • Ongoing Z-0657-2025 FDA Class I initiated 14 Nov 2024

    Potential for the outer stainless-steel tube to break or detach.

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  • Withdrawn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
Kirwan
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Model / Reference
14-5011L
Primary DI / UDI-DI
00841019101056
Basic UDI-DI
B-00841019101056
510(k) Number
FDA Product Code
GEI
EMDN Code
K0201010501 Open electrosurgery handpieces, single-use
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008222
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Other devices from Kirwan Surgical Products LLC

See all devices from Kirwan Surgical Products LLC →

Properties

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

Other properties (17)

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