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Reusable Thermoplastic Rubber Bipolar Pencil 20 Gauge, 10mm Extended Center Tip

by Kirwan Surgical Products LLC United States EUDAMEDGUDID

Ref 14-7013

Product code GEIEMDN L180301

Regulatory status

as of 24 Oct 2026

Recall ongoing. 7 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841019103722 Basic UDI-DIDate30 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00841019103722 UDI-DIDate18 Apr 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

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.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Kirwan
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Model / Reference
14-7013
Primary DI / UDI-DI
00841019103722
Basic UDI-DI
B-00841019103722
510(k) Number
FDA Product Code
GEI
EMDN Code
L180301 Open electrosurgery handpieces, reusable
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam 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

Other devices from Kirwan Surgical Products LLC

See all devices from Kirwan Surgical Products LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Expiration Date: No

Sources (2)

  • EUDAMED bd3b4fac-5e42-4107-bfec-83f02d207b60 61 fields · synced 22 Oct 2026
  • FDA UDI 2db73aa7-e581-4e05-9d65-4fd6a326734a 35 fields · synced 30 May 2026