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Rochester 035689

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 Number10816843020061 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  • Withdrawn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
Rochester
Generic Name
Analytical non-scalp cutaneous lead
Model / Reference
035689
Primary DI / UDI-DI
10816843020061
FDA Product Code
GXY
GMDN Term
Analytical non-scalp cutaneous lead
Device Class
Class II
Regulation Number
882.1320
GUDID distribution status
Not in Commercial Distribution

Other devices from Rochester Electro-Medical, Inc.

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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