Primary Device ID | 00815671020048 |
NIH Device Record Key | f7d07678-253d-4f03-b933-607b8fddae41 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Magellan™ |
Version Model Number | MACC50 |
Catalog Number | MACC50 |
Company DUNS | 128941304 |
Company Name | HANSEN MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-866-426-0804 |
xx@xx.xx | |
Phone | 1-866-426-0804 |
xx@xx.xx | |
Phone | 1-866-426-0804 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815671020048 [Primary] |
DXX | System, Catheter Control, Steerable |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-08-09 |
Device Publish Date | 2016-09-23 |
00815671020321 | Magellan Robotic System 120V |
00815671020314 | Magellan Transport System |
00815671020284 | Magellan Robotic System 120V |
00815671020239 | Magellan Robotic Catheter 6Fr & eKit Leader 95cm |
00815671020222 | Magellan Robotic Catheter 6Fr & eKit Leader 60cm |
00815671020215 | Magellan Robotic Catheter eKit Accessory Kit 95cm |
00815671020208 | Magellan Robotic Catheter eKit Accessory Kit 60cm |
00815671020192 | Magellan Robotic Catheter eKit 6Fr Guide 95cm |
00815671020185 | Magellan eKit 6Fr Guide 60cm |
00815671020178 | Magellan Robotic Catheter 10Fr 80cm |
00815671020161 | Magellan Robotic Catheter 10Fr 65cm |
00815671020154 | Magellan Robotic Catheter 10Fr 50cm |
00815671020147 | Magellan Robotic Catheter 6Fr Accessory Kit 95cm |
00815671020130 | Magellan Robotic Catheter 6Fr Accessory Kit 60cm |
00815671020123 | Magellan Robotic Catheter 6Fr Guide 95cm |
00815671020116 | Magellan Robotic Catheter 6Fr Guide 60cm |
00815671020079 | Magellan Robotic Catheter 9Fr & 10Fr Caddy |
00815671020062 | Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 80cm |
00815671020055 | Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 65cm |
00815671020048 | Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 50cm |
00815671020031 | Magellan Robotic Catheter 9Fr 80cm |
00815671020024 | Magellan Robotic Catheter 9Fr 65cm |
00815671020017 | Magellan Robotic Catheter 9Fr 50cm |