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E Surgical EPEN01

by New Deantronics Taiwan, Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813527023960 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
E Surgical
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Model / Reference
EPEN01
Description
Disposable Electrosurgical Hand Control Pencil, Button Handswitch, with 10ft Cord
Primary DI / UDI-DI
00813527023960
FDA Product Code
GEI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
In Commercial Distribution

Other devices from New Deantronics Taiwan, Ltd.

See all devices from New Deantronics Taiwan, Ltd. →

Properties

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

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No