UniFuse 12401801

by Angiodynamics, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberH787124018010 UDI-DI	Date19 Sep 2016Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: UniFuse
Generic name: Peripheral vascular intervention infusion catheter
Model / reference: 12401801

Primary DI / UDI-DI: H787124018010
FDA product code: KRA
GMDN term: Peripheral vascular intervention infusion catheter

Device class: Class II
Regulation number: 870.1210
GUDID distribution status: Not in Commercial Distribution

Size: Length — 45 Centimeter
Outer Diameter — 1.71 Millimeter
Catheter Gauge — 5 French

Other devices from Angiodynamics, Inc.

AngioDynamics H787TDST0

Class I
AngioDynamics H787065200010

Class II
NanoKnife H78720300301US0 Open recall

Class II
NanoKnife H787204001090 Open recall

Class II
NanoKnife H787204003010 Open recall

Class II
NanoKnife H787204001100 Open recall

Class II

See all devices from Angiodynamics, Inc. →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10)

Sterilise before use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No