AccessGUDID - DEVICE: Integra DP Valve System (10381780033578)

GUDID

Device Identifier (DI) Information

Brand Name: Integra DP Valve System
Version or Model: 908112
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 908112
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780033578
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: Integra DP Valve System is an implantable device which serves as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site (differential pressure valve). It provides controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired. The very low pressure valve (blue band) is used for postoperative drainage of hygromas and other extraventricular conditions.

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:	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?
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 [?]
K152897	000
K861377	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: Operating Pressure Range (VERY LOW): 15-40mmH2O, Distal Cath. 110cm 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), Burr Hole Reservoir 6.4mm Diam.

Device Record Status

Public Device Record Key: 3a30924b-145d-4ab6-b35e-80b6d4fc9681
Public Version Date: March 18, 2024
Public Version Number: 5
DI Record Publish Date: October 01, 2015