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Valleylab SEP5015NSB

by Covidien LP

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20884521750903 UDI-DIDate6 Aug 2023ListedStatusListed GUDID: not 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  • Withdrawn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
Valleylab
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Model / Reference
SEP5015NSB
Primary DI / UDI-DI
20884521750903
510(k) Number
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
Not in Commercial Distribution
Size
Length — 4.6 Meter

Related devices

Cleared under the same submission (K182772)

Other devices from Covidien LP

See all devices from Covidien LP →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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