AccessGUDID - DEVICE: Dual Outlet Convertible Integra™ Reservoir (10381780112273)

GUDID

Device Identifier (DI) Information

Brand Name: Dual Outlet Convertible Integra™ Reservoir
Version or Model: NL79034S02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL79034S02
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780112273
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: The silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, is designed to provide access to the brain and/or CSF. The Convertible model incorporates an outlet tube in addition to an inlet tube. The outlet tube may be connected to a distal catheter, allowing the reservoir to be used in a shunting system, if later indicated. The 2.5cm base diameter reservoir is a flat bottom design; the 1.5cm base diameter reservoir is a burr-hole model.

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: Reservoir: 2.5cm Intet tube: 1.4mm I.D. x 2.8mm O.D. (All dimensions nominal)

Device Record Status

Public Device Record Key: e744a3cf-4e1e-48da-8e5c-48d9591fc683
Public Version Date: December 01, 2022
Public Version Number: 4
DI Record Publish Date: December 15, 2016