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MedSource Electrodes MS-65003-RCS

by Medsource International LLC

MedSource Electrodes MS-65003-RCS (Not Applicable) is a Class II device made by Medsource International LLC, cleared under FDA 510(k) K093327 on 10 May 2010 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 00816703028629), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K093327

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816703028629 UDI-DI Date15 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK093327 Date10 May 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093327 decided 10 May 2010 Active
  • FDA GUDID UDI-DI 00816703028629 listed 15 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K093327
  2. Listed FDA GUDID 00816703028629

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MedSource Electrodes
Generic name
External defibrillation electrode, paediatric, single-use
Model / Ref / Catalog
MS-65003-RCS, Not Applicable
Primary DI / UDI-DI
00816703028629
510(k) Number
FDA product code
DRX
GMDN term
External defibrillation electrode, paediatric, single-use
Device class
Class II
Regulation number
870.2360
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DRX (Electrode, Electrocardiograph).

Other devices from Medsource International LLC

See all devices from Medsource International LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)