AccessGUDID - DEVICE: Mini Integra® (10381780072225)

GUDID

Device Identifier (DI) Information

Brand Name: Mini Integra®
Version or Model: NL83026S02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL83026S02
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: Mini Integra® CSF Reservoir, Side-Inlet

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?
35965	Cerebrospinal fluid shunt valve	An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.	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: Diameter: 16mm; Inlet Tube: 1.2mm I.D. x 2.2mm O.D. (All dimensions nominal)

Device Record Status

Public Device Record Key: 5b09699e-8a52-4dd3-b819-4d8e81dbc39b
Public Version Date: May 16, 2023
Public Version Number: 6
DI Record Publish Date: December 15, 2016