← Back to catalogue

Magellan™

FDA UDI

Class II (US FDA UDI)

by Hansen Medical, Inc.

Identity

Trade Name
Magellan™ FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Magellan Robotic Catheter 6Fr Guide 95cm FDA UDI
Model / Reference
MC6F95 FDA UDI
Description
Magellan Robotic Catheter 6Fr Guide 95cm FDA UDI

Identifiers

Catalog Number
MC6F95 FDA UDI
Primary DI / UDI-DI
00815671020123 FDA UDI
FDA Product Code
DRA FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1280 FDA UDI
Commercial Distribution
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

Category: Vascular guide-catheter, single-use

Magellan™ by Hansen Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

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
Hansen Medical, Inc.

Sources (1)

  • FDA UDI 39f3b9ed-9387-4fd0-8919-b3645ecf7d7e 35 fields · synced Jun 1, 2026