Gravity Compensating Accessory

Basic Information

• Brand Name: Gravity Compensating Accessory
• Primary DI: 10381780033523
• Version / Model: 903435
• Catalog Number: 903435
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 9bae6f0e-b3fe-4478-a4cd-40dbbf10bcb5

Device Description

The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61123	Ventriculo-peritoneal/atrial shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780033523	GS1
Secondary	M2729034351	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152897	000
K932429	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O