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Magellan™

FDA UDI

Class II (US FDA UDI)

by Hansen Medical, Inc.

Identity

Trade Name
Magellan™ FDA UDI
Generic Name
Instrument/equipment drape, single-use, sterile FDA UDI
Device Name
Magellan Robotic System Sterile Drape FDA UDI
Model / Reference
MD6PK FDA UDI
Description
Magellan Robotic System Sterile Drape FDA UDI

Identifiers

Catalog Number
MD6PK FDA UDI
Primary DI / UDI-DI
10815671020083 FDA UDI
FDA Product Code
DXX FDA UDI
GMDN Term
Instrument/equipment drape, single-use, 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: Instrument/equipment drape, single-use, sterile

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

Similar devices

Also classified as Instrument/equipment drape, single-use, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hansen Medical, Inc.

Sources (1)

  • FDA UDI 66ed4bf8-ddbb-408e-ae4e-32647ac4b69c 35 fields · synced May 30, 2026