AccessGUDID - DEVICE: Integra Pudenz Ventricular Catheter (10381780071792)

GUDID

Device Identifier (DI) Information

Brand Name: Integra Pudenz Ventricular Catheter
Version or Model: NL96001S01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL96001S01
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780071792
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: STRIPED PUD. VENTRICULAR CATHETER The Integra Pudenz Ventricular Cather is designed for shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The Large Hole Model is manufactured from a high durometer silicone elastomer, which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate-impregnated silicone elastomer, is imbedded in the wall of the catheter. The stripe provides a catheter which is radiopaque throughout its entire length, while keeping barium sulfate away from the surface of the catheter and allowing visual observation of flow through the catheter during implantation. The catheter has four pairs of holes near the tip to facilitate drainage of CSF and to help reduce clogging of the catheter lumen. The extreme tip of the catheter is closed. The catheter incorporates markers at 5, 6, 7, 10 and 15 cm. A stylet is provided, along with a right-angle guide.

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?
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 [?]
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
Device Size Text, specify: Tubing: 1.3mm ID x 2.5mm OD; Total Length: 20cm (8") (all dimensions nominal)

Device Record Status

Public Device Record Key: 4a053d95-ee9d-42ab-a368-ab58fac14d4f
Public Version Date: September 22, 2020
Public Version Number: 4
DI Record Publish Date: September 22, 2015