FDA.reportPublic FDA data

Magellan™

Primary DI
10815671020083
Brand
Magellan™
Company
HANSEN MEDICAL, INC.
Model
MD6PK
Catalog number
MD6PK
Device description
Magellan Robotic System Sterile Drape
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXXSystem, Catheter Control, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXXSystem, Catheter Control, SteerableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815671020086PackageGS16In Commercial Distribution
10815671020083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815671020086008156710200868156710200860815671020086
1081567102008310815671020083

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-650-404-5844xx@xx.xx
1-866-426-0804xx@xx.xx

Regulatory Flags#

DUNS number
128941304
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815671020079Magellan™MRCCADMRCCAD2016-09-23
00815671020017Magellan™MC9F50MC9F502016-09-23
00815671020024Magellan™MC9F65MC9F652016-09-23
00815671020031Magellan™MC9F80MC9F802016-09-23
00815671020116Magellan™MC6F60MC6F602016-09-23
00815671020123Magellan™MC6F95MC6F952016-09-23
00815671020154Magellan™MC10F50MC10F502016-09-23
00815671020161Magellan™MC10F65MC10F652016-09-23
00815671020178Magellan™MC10F80MC10F802016-09-23
00815671020185Magellan™MCE60MCE602016-09-23
00815671020192Magellan™MCE95MCE952016-09-23
00815671020222Magellan™ML60ML602016-09-23
00815671020239Magellan™ML95ML952016-09-23
00815671020048Magellan™MACC50MACC502016-09-23
00815671020055Magellan™MACC65MACC652016-09-23
00815671020062Magellan™MACC80MACC802016-09-23
00815671020130Magellan™MA6F60MA6F602016-09-23
00815671020147Magellan™MA6F95MA6F952016-09-23
00815671020208Magellan™MAE60MAE602016-09-23
00815671020215Magellan™MAE95MAE952016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M58800101400010GenesisXStereotaxis, Inc.DXX2026-01-09
07290019564003LIBERTY Endovascular Robotic SystemMICROBOT MEDICAL LTDDXX2025-11-18
07290019564058LIBERTY Endovascular Robotic System - robotMICROBOT MEDICAL LTDDXX2025-11-18
07290019564102LIBERTY Endovascular Robotic System - armMICROBOT MEDICAL LTDDXX2025-11-18
00816280023192CorPath GRX Cassette DuoCorindus, Inc.DXX2022-08-08
00816280023185CorPath GRX Cassette DuoCORINDUS, INC.DXX2022-08-08
00816280023123CorPath GRX Extended Reach ArmCorindus, Inc.DXX2018-04-05
00816280023017CorPath GRX Control ConsoleCorindus, Inc.DXX2017-01-20
00816280023024CorPath GRX Extended Reach ArmCorindus, Inc.DXX2017-01-20
00816280023031CorPath GRX Robotic DriveCorindus, Inc.DXX2017-01-20
00816280023055CorPath GRX CassetteCorindus, Inc.DXX2017-01-20
00816280023079CorPath GRX Drive GearCorindus, Inc.DXX2017-01-20
00816280023093CorPath GRX Drape, Robotic Drive and ArmCorindus, Inc.DXX2017-01-20
00816280023116CorPath GRX Drape, Control ConsoleCorindus, Inc.DXX2017-01-20
00815671020246Sensei®HANSEN MEDICAL, INC.DXX2016-09-30
00815671020260Sensei®HANSEN MEDICAL, INC.DXX2016-09-30
00815671020284Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020314Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00815671020321Magellan™HANSEN MEDICAL, INC.DXX2016-09-30
00816280022010CorPath 200 Control ConsoleCorindus, Inc.DXX2016-09-24
00816280022027CorPath 200 Articulated ArmCorindus, Inc.DXX2016-09-24
00816280022034CorPath 200 Robotic DriveCorindus, Inc.DXX2016-09-24
00816280022041CorPath 200 CassetteCorindus, Inc.DXX2016-09-24
00816280022072CorPath 200 POGO Pin CapsCorindus, Inc.DXX2016-09-24
00816280022096CorPath 200 Control Console DrapeCorindus, Inc.DXX2016-09-24
00816280022119CorPath 200 Joystick CoversCorindus, Inc.DXX2016-09-24
00816280022133CorPath 200 Robotic Drive DrapeCorindus, Inc.DXX2016-09-24
10815671020007Artisan®HANSEN MEDICAL, INC.DXX2016-09-23
00815671020048Magellan™HANSEN MEDICAL, INC.DXX2016-09-23
00815671020055Magellan™HANSEN MEDICAL, INC.DXX2016-09-23