Gravity Compensating Accessory 903435

GUDID 10381780033523

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).

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt
Primary Device ID10381780033523
NIH Device Record Key9bae6f0e-b3fe-4478-a4cd-40dbbf10bcb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGravity Compensating Accessory
Version Model Number903435
Catalog Number903435
Company DUNS531408342
Company NameINTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780033523 [Primary]
HIBCCM2729034351 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2015-10-01

On-Brand Devices [Gravity Compensating Accessory]

10381780033530The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on th
10381780033523The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on th
10381780033516The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on th
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