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UltraPoint™ 016383

by Rochester Electro-Medical, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10816843022478 UDI-DIDate24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
UltraPoint™
Generic Name
Electromyographic needle electrode, single-use
Model / Reference
016383
Primary DI / UDI-DI
10816843022478
FDA Product Code
IKT
GMDN Term
Electromyographic needle electrode, single-use
Device Class
Class II
Regulation Number
890.1385
GUDID distribution status
Not in Commercial Distribution

Other devices from Rochester Electro-Medical, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No