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Flexon 88862586-43

by Covidien LP

Listed FDA GUDID listing, not in commercial distribution

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 Number10884521103719 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: not 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  • Withdrawn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

Trade Name
Flexon
Generic Name
Transthoracic pacing lead
Model / Reference
88862586-43
Primary DI / UDI-DI
10884521103719
510(k) Number
FDA Product Code
LDF
GMDN Term
Transthoracic pacing lead
Device Class
Class II
Regulation Number
870.3680
GUDID distribution status
Not in Commercial Distribution
Size
Length — 24 Inch

Related devices

Cleared under the same submission (K955722)

Show all (9)

Other devices from Covidien LP

See all devices from Covidien LP →

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