AccessGUDID - DEVICE: PulseRider Aneurysm Neck Reconstruction Device (00859030005154)

GUDID

Device Identifier (DI) Information

Brand Name: PulseRider Aneurysm Neck Reconstruction Device
Version or Model: 201-D
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 201-D
Company Name: Medos International Sàrl

Primary DI Number: 00859030005154
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, 2.7 to 3.5 mm, 8 mm, T Shape

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
46352	Bare-metal intracranial vascular stent	A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NJE	Intracranial Neurovascular Stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 59ec5da1-3366-404b-8d31-233200dac4a2
Public Version Date: March 12, 2024
Public Version Number: 10
DI Record Publish Date: August 31, 2017