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Surelead EXTGE6PL8F

by Authentic Medical

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB631EXTGE6PL8F1 UDI-DI Date13 Mar 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  • Withdrawn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
Surelead
Generic Name
Electrocardiographic lead switching adaptor
Model / Reference
EXTGE6PL8F
Primary DI / UDI-DI
B631EXTGE6PL8F1
FDA Product Code
IKD
GMDN Term
Electrocardiographic lead switching adaptor
Device Class
Class II
Regulation Number
890.1175
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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