AccessGUDID - DEVICE: Integra NeuroSciences Connector (10381780024392)

GUDID

Device Identifier (DI) Information

Brand Name: Integra NeuroSciences Connector
Version or Model: NL8501913
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NL8501913
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780024392
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: THREADED RIGHT ANGLE CONNECTOR One end of the Threaded Right-Angle Connector is identical to the ends of the standard connector. The other end is manufactured with threads to join spring-reinforced ventricular catheters to plain silicone elastomer tubing and flushing devices were a 90 degree bend is desired, and when the bendable feature of a spring-reinforced ventricular catheter is not utilized. A reduced diameter tip facilitates insertion of a connector into a catheter tube. A single groove is considered standard and is located near each connector end to accommodate a ligature. This type of end is inserted into flushing devices and all catheters that are not spring-reinforced. The connector threads help improve the grip between the connected and the catheter.

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":	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?
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 [?]
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
Special Storage Condition, Specify: SpeciaAvoid contaminants such as lint, fingerprints, or talc.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.1mm ID x 1.9mm OD (all dimensions nominal)

Device Record Status

Public Device Record Key: e8bfb40f-211d-4f26-85d4-5496fefc759d
Public Version Date: March 18, 2024
Public Version Number: 5
DI Record Publish Date: December 15, 2016