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UltraLinq 58.13

by Ultralinq Healthcare Solutions, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00862894000302 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
UltraLinq
Generic Name
Multidisciplinary medical image management software
Model / Reference
58.13
Primary DI / UDI-DI
00862894000302
510(k) Number
FDA Product Code
LLZ
GMDN Term
Multidisciplinary medical image management software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
Not in Commercial Distribution

Other devices from Ultralinq Healthcare Solutions, Inc.

  • UltraLinq

    Class II

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