AccessGUDID - DEVICE: Integra NeuroSciences Connector (10381780071211)

GUDID

Device Identifier (DI) Information

Brand Name: Integra NeuroSciences Connector
Version or Model: NL75121S06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL75121S06
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780071211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: The lumbar-peritoneal shunt connector is manufactured from stainless steel material. 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. A threaded (or multi-grooved) end is designed for insertion into spring-reinforced catheters, ventricular or peritoneal models.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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 [?]
K811288	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
Special Storage Condition, Specify: Avoid contaminants such as lint, fingerprints, or talc.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.635mm ID x 1.1938mm OD (all dimensions nominal)

Device Record Status

Public Device Record Key: cb34707f-78d9-4acb-8cfc-25081c351763
Public Version Date: April 07, 2021
Public Version Number: 5
DI Record Publish Date: September 22, 2015