AccessGUDID - DEVICE: PulseRider (00859030005253)

GUDID

Device Identifier (DI) Information

Brand Name: PulseRider
Version or Model: PRDSCBD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PRDSCBD
Company Name: Medos International Sàrl

Primary DI Number: 00859030005253
Issuing Agency: GS1
Commercial Distribution End Date: March 07, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: PulseRider Aneurysm Neck Reconstruction Device Detachment System Controller

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: ad46678e-bdeb-40e7-96e0-5c009d635de5
Public Version Date: March 12, 2024
Public Version Number: 6
DI Record Publish Date: September 17, 2019