AccessGUDID - DEVICE: Contour-Flex Valve and Shunt System (10381780457329)

GUDID

Device Identifier (DI) Information

Brand Name: Contour-Flex Valve and Shunt System
Version or Model: 11813
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11813
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780457329
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use
Previous DI: 10381780032823

Device Description: Contour-Flex Valve and Shunt System Contour-Flex Valve System, Regular, High Pressure for ventricular shunting of cerebrospinal fluid.

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":	Yes
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?
61123	Ventriculo-peritoneal/atrial shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. Disposable devices associated with implantation may be included.	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: High Pressure at 20ml/h: 12.7-18.0cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm 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: 6f7f789f-6b2e-495d-87a9-e47331675385
Public Version Date: July 26, 2024
Public Version Number: 6
DI Record Publish Date: January 12, 2018