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Piccolo Medical FGN-15-779

by Piccolo Medical, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number00860002238524 UDI-DI Date19 Nov 2025ListedStatusListed GUDID: 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  • Withdrawn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
Piccolo Medical
Generic Name
Central venous catheter navigation system control unit
Model / Ref / Catalog
FGN-15-779
Primary DI / UDI-DI
00860002238524
510(k) Number
FDA Product Code
LJS, DSA
GMDN Term
Central venous catheter navigation system control unit
Device Class
Class II
Regulation Number
880.5970, 870.2900
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243484)

Other devices from Piccolo Medical, Inc.

See all devices from Piccolo Medical, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No