AccessGUDID - DEVICE: CERENOVUS ENTERPRISE (10886704044017)

GUDID

Device Identifier (DI) Information

Brand Name: CERENOVUS ENTERPRISE
Version or Model: ENF451412
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ENF451412
Company Name: Medos International Sàrl

Primary DI Number: 10886704044017
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 14mm. 12mm Distal tip. Maximum Stent foreshortening 1.1mm, Recommended Microcatheter .021inch(0.533mm)

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 [?]
H060001	012

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
Special Storage Condition, Specify: Do not use if opened or damaged.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36e2719f-929c-4897-8104-0498483eb863
Public Version Date: October 12, 2021
Public Version Number: 6
DI Record Publish Date: September 20, 2014