DEVICE: PulseRider (00859030005253)

Device Identifier (DI) Information

PulseRider
PRDSCBD
Not in Commercial Distribution
PRDSCBD
Medos International Sàrl
00859030005253
GS1
March 07, 2024
1
482661753 *Terms of Use
PulseRider Aneurysm Neck Reconstruction Device Detachment System Controller
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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
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FDA Product Code

[?]
Product Code Product Code Name
NJE Intracranial Neurovascular Stent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
H160002 000
H160002 002
H160002 008
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ad46678e-bdeb-40e7-96e0-5c009d635de5
March 12, 2024
6
September 17, 2019
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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