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Symmetry Jewelers 08-0001

by Aspen Surgical Products, Inc.

Ref 08-0001

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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/MDR EUDAMED Number08401132BipolarForcepRZV Basic UDI-DI 00841785112331UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841785112331 UDI-DI Date17 May 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 · FDA

    • Terminated Z-1944-2018 FDA Class II initiated 11 May 2018

    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Olsen® EUDAMED
Symmetry Jewelers GUDID
Symmetry Olsen GUDID
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device Name
Forceps, Bipolar (reusable)
Model / Ref / Catalog
08-0001
Primary DI / UDI-DI
00841785112331, 00887482138984
Basic UDI-DI
08401132BipolarForcepRZV
Direct Marketing DI
00841785112331
FDA Product Code
GEI
EMDN Code
L180401 Open electrosurgery forceps, reusable
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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
Moist Heat or Steam Sterilization
Size
Length — 4 Inch
Width — 0.4 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

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

Cleared under the same submission (K974594)

Show all (12)

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Serial Number: No
  • Expiration Date: No