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INTRAcel Handpiece

by Jeisys Medical Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800020110565 UDI-DI Date16 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Electrosurgical system
Model / Reference
INTRAcel Handpiece
Primary DI / UDI-DI
08800020110565
510(k) Number
FDA Product Code
GEI
GMDN Term
Electrosurgical system
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K183284)

Show all (12)

Other devices from Jeisys Medical Incorporated

See all devices from Jeisys Medical Incorporated →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No