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Diathermy cable for forceps 1115 & 1116 1115.A

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ref 1115.A

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

Recall on shared 510(k) K190875; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08717872000336 Basic UDI-DI 08717872000336UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717872000336 UDI-DI Date23 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.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2252-2021 FDA Class II initiated 21 May 2019 on shared 510(k) K190875

    Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Diathermy cable for forceps 1115 & 1116
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Model / Ref / Catalog
1115.A
Primary DI / UDI-DI
08717872000336
Basic UDI-DI
B-08717872000336
Direct Marketing DI
08717872000336
510(k) Number
FDA Product Code
HQR
EMDN Code
Z1212020685 Ophthalmic electrosurgery instruments - consumables
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
886.4100
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Cleared under the same submission (K190875)

Show all (12)

Other devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

See all devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. →

Properties

  • Reusable
  • Prescription Use
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No