← Back to catalogue

Gandras® catheters

FDA UDI

Class II (US FDA UDI)

by Vascular Solutions, Inc.

Identity

Trade Name
Gandras® catheters FDA UDI
Generic Name
Angiographic catheter, single-use FDA UDI
Device Name
The GANDRAS catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. FDA UDI
Model / Reference
5581 FDA UDI
Description
The GANDRAS catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. FDA UDI

Identifiers

Primary DI / UDI-DI
M20655810 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Angiographic catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 5 French FDA UDI
Length — 84 Centimeter FDA UDI

Gandras® catheters by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vascular Solutions, Inc.

Sources (1)

  • FDA UDI af29f830-344c-4a0f-a73b-9c1a3dacf24c 36 fields · synced May 30, 2026