AccessGUDID - DEVICE: Stainless Steel Connector (10381780033387)

GUDID

Device Identifier (DI) Information

Brand Name: Stainless Steel Connector
Version or Model: 901415
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 901415
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780033387
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: Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.

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?
47515	Cerebrospinal fluid shunt connector	An implantable device intended to create a fluid path connection between components of a cerebrospinal fluid (CSF) shunt assembly (e.g., lumbar and/or peritoneal catheters of a ventriculoperitoneal or lumboperitoneal shunt), designed to remove excess cerebrospinal fluid from around the central nervous system especially in the treatment of hydrocephalus. It is typically made of plastic or metal and is available in various designs (L-, Y- or cross-shaped, straight).	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 [?]
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: 0.8mm I.D. x 1.8mm and 1.5mm O.D.

Device Record Status

Public Device Record Key: 45ad95a0-e9cd-47e2-b749-b4a7213adc40
Public Version Date: February 17, 2023
Public Version Number: 5
DI Record Publish Date: October 01, 2015