AccessGUDID - DEVICE: pNOVUS 21 Microcatheter (160cm) (05391530910392)

GUDID

Device Identifier (DI) Information

Brand Name: pNOVUS 21 Microcatheter (160cm)
Version or Model: PNOV-21-160
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHENOX LIMITED

Primary DI Number: 05391530910392
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985621869 *Terms of Use

Device Description: The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	Catheter, Intravascular, Diagnostic
QJP	Catheter, Percutaneous, Neurovasculature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242420	000

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
Catheter Length: 160 Centimeter

Device Record Status

Public Device Record Key: 2ffda539-c4aa-498c-8dd3-fd8876dc7192
Public Version Date: December 10, 2024
Public Version Number: 1
DI Record Publish Date: December 02, 2024