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Evala nerve stimulator EPNR002

by Epineuron Technologies, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860013827106 UDI-DIDate17 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Evala nerve stimulator
Generic Name
Nerve-locating system
Model / Reference
EPNR002
Primary DI / UDI-DI
00860013827106
510(k) Number
FDA Product Code
ETN
GMDN Term
Nerve-locating system
Device Class
Class II
Regulation Number
874.1820
GUDID distribution status
In Commercial Distribution

Other devices from Epineuron Technologies, Inc.

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