AccessGUDID - DEVICE: Ventricular Catheter (10381780034674)

GUDID

Device Identifier (DI) Information

Brand Name: Ventricular Catheter
Version or Model: 14M02
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 14M02
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034674
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with full barium impregnation. Numbered length markers are located 5 and 10 cm from the proximal end. Length marker dots are located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end presents thirthy-two (32) flow holes. The proximal tip is constructed of molded, barium sulfate impregnated silicone to provide smooth, consistent end, which aid catheter placement. A stainless steel stylet and a right angle guide are provided.

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 [?]
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: Straight Vent. Cath. 25cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.

Device Record Status

Public Device Record Key: 0982a280-b94a-4606-bc22-f9412cd0369e
Public Version Date: June 30, 2021
Public Version Number: 4
DI Record Publish Date: October 01, 2015