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Evoke® Clarity® Programming Application 3044

by Saluda Medical Pty Limited 2 variants

Listed FDA GUDID listing, no authorization on record

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 Number09352307002111 UDI-DI Date6 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
Evoke® Clarity® Programming Application
Generic Name
Implantable electrical stimulation device management software
Model / Reference
3044
Primary DI / UDI-DI
09352307002111
PMA Number
FDA Product Code
LGW, QRB
GMDN Term
Implantable electrical stimulation device management software
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P190002)

Show all (12)

Other devices from Saluda Medical Pty Limited

See all devices from Saluda Medical Pty Limited →

Properties

  • Prescription Use

Other properties (13)

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