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Magellan™

FDA UDI

Class II (US FDA UDI)

by Hansen Medical, Inc.

Identity

Trade Name
Magellan™ FDA UDI
Generic Name
General-purpose catheter connector, sterile FDA UDI
Device Name
Magellan Robotic Catheter 6Fr Accessory Kit 60cm FDA UDI
Model / Reference
MA6F60 FDA UDI
Description
Magellan Robotic Catheter 6Fr Accessory Kit 60cm FDA UDI

Identifiers

Catalog Number
MA6F60 FDA UDI
Primary DI / UDI-DI
00815671020130 FDA UDI
FDA Product Code
DXX FDA UDI
GMDN Term
General-purpose catheter connector, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1290 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: General-purpose catheter connector, sterile

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

Similar devices

Also classified as General-purpose catheter connector, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 3b31bab5-1df9-47bf-979b-038c4c4aa689 35 fields · synced Jun 6, 2026