Skip to content

Aesculap US989SU

by Aesculap, Inc.

Aesculap US989SU is a Class II device made by Aesculap, Inc., listed in FDA GUDID since 31 Oct 2025 (UDI-DI 04046955920426), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04046955920426 UDI-DI Date31 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Aesculap
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Model / Ref / Catalog
US989SU
Primary DI / UDI-DI
04046955920426
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, cutting & coagulation & accessories).

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)