DEVICE: PulseRider (00859030005253)
Device Identifier (DI) Information
PulseRider
PRDSCBD
Not in Commercial Distribution
PRDSCBD
Medos International Sàrl
PRDSCBD
Not in Commercial Distribution
PRDSCBD
Medos International Sàrl
PulseRider Aneurysm Neck Reconstruction Device Detachment System Controller
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61754 | Vascular implant detacher, electronic, reusable |
A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NJE | Intracranial Neurovascular Stent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
H160002 | 000 |
H160002 | 002 |
H160002 | 008 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit |
Handling Environment Temperature: between 0 and 40 Degrees Celsius |
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit |
Storage Environment Temperature: between 0 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ad46678e-bdeb-40e7-96e0-5c009d635de5
March 12, 2024
6
September 17, 2019
March 12, 2024
6
September 17, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx