AccessGUDID - DEVICE: Ventricular Catheter (10381780035923)

GUDID

Device Identifier (DI) Information

Brand Name: Ventricular Catheter
Version or Model: 9MZ210
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9MZ210
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780035923
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer diameter 2.7mm). They are delivered with an Introducer. Marked Ventricular Catheters feature radiopaque Length Markings at 2.0 cm Intervals from the Tip. A Straight or Right Angle Connector, and/or a silicone Right Angle Guide, are supplied as Accessories.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911433	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
Device Size Text, specify: 10cm Proximal Length x 2cm Distal Length x 2.7mm O.D. x 1.4mm I.D. (F8)

Device Record Status

Public Device Record Key: 3c53993d-a4f7-40db-81ce-a3e9728f7cbd
Public Version Date: February 09, 2023
Public Version Number: 4
DI Record Publish Date: October 01, 2015