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ECG Snap Electrodes 7101

by Dynarex Corp.

ECG Snap Electrodes 7101 is a Class II device made by Dynarex Corp., cleared under FDA 510(k) K093327 on 10 May 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00616784710129), active as of 23 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 23 Oct 2026

Documents

510(k) K093327

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00616784710129 UDI-DI Date24 Sep 2016ListedStatusListed 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 00616784710129 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K093327
  2. Listed FDA GUDID 00616784710129

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ECG Snap Electrodes
Generic name
Electrocardiographic electrode, single-use
Model / reference
7101
Primary DI / UDI-DI
00616784710129
510(k) Number
FDA product code
DRX
GMDN term
Electrocardiographic electrode, single-use
Device class
Class II
Regulation number
870.2360
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)