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Epad

by Safeop Surgical, Inc. 21 variants

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851641007008 UDI-DI Date14 Dec 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Evoked-potential graphic recording system
Model / Ref / Catalog
EPAD, 100085
Primary DI / UDI-DI
00851641007008
FDA Product Code
IKN, GXY, GWF
GMDN Term
Evoked-potential graphic recording system
Device Class
Class II
Regulation Number
890.1375, 882.1320, 882.1870
GUDID distribution status
Not in Commercial Distribution

Other devices from Safeop Surgical, Inc.

  • Epad

    Class II

  • The EPAD 2 System

    Class II

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

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