AccessGUDID - DEVICE: Burr Hole Reservoir (10381780034322)

GUDID

Device Identifier (DI) Information

Brand Name: Burr Hole Reservoir
Version or Model: 955111
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 955111
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034322
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Burr Hole Reservoir is a component of a central nervous system (CNS) fluid shunt. It is used to connect the ventricular catheter to a silicone elastomer burr hole reservoir cap with integral side-arm leading to the valve tubing. It may also be used as a CSF reservoir with a ventricular catheter alone when a burr hole cap without side-arm is used. Configurations include 6.4 mm or 10 mm outer diameter reservoir and regular (2.5 mm) or shallow (0.8 mm) depth.

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:	Yes
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?
61375	Cranial port/reservoir	A sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device.	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 [?]
K152897	000
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: Shallow Reservoir 0.8mm Depth x 6.4mm Diam., Cap Side Arm 2.7mm O.D. x 1.4mm I.D. (F8)

Device Record Status

Public Device Record Key: acef2736-fda0-4256-8c68-ef3f42f3b830
Public Version Date: February 09, 2023
Public Version Number: 4
DI Record Publish Date: October 01, 2015