Integra Peritoneal Reflux Control Catheter NL8501375

GUDID 10381780024293

PERITONEAL REFLUX CONTROL CATHETER The Integra Peritoneal Reflux Control Catheter is designed to deliver cerebrospinal fluid (CSF) to the peritoneal cavity with minimum flow resistance. This catheter is recommended for use with pressure control valves located proximally in the hydrocephalic shunt system. This catheter has a series of slits located along the catheter’s distal section. These slits, made up of one set of four slits at the catheter’s distal end and two sets of two slits spaced at 2.5cm intervals along the catheter help resist retrograde flow of CSF while minimizing occlusion at the distal catheter tip. The catheter is made of a high durometer silicone elastomer which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate impregnated silicone elastomer, is imbedded in the wall of the catheter. The distal tip of the catheter is filled with radiopaque tantalum impregnated silicone elastomer. The maximum flow resistance is 50mm H2O at a flow rate of 23 ml/hr.

Integra Lifesciences Corporation

Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter Peritoneal/atrial cerebrospinal fluid catheter
Primary Device ID10381780024293
NIH Device Record Key6d52a528-6ec6-4335-8182-a1f22165d05b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra Peritoneal Reflux Control Catheter
Version Model NumberNL8501375
Catalog NumberNL8501375
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780024293 [Primary]
HIBCCM269NL85013751 [Secondary]

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 Number3
Public Version Date2020-09-22
Device Publish Date2016-12-15

Devices Manufactured by Integra Lifesciences Corporation

M268WRISTFUSESET0 - Integra® Total Wrist Fusion System2024-04-05 The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nin
M248437A2224SRL1 - MAYFIELD®2024-04-05 MAYFIELD® XR2 Extension Arm Assembly
M2483138R1 - Omni-Tract®2024-04-05 Deaver Fixed Retractor, 2.75in x 4.5in (7.0cm x 11.4cm)
M2483086P1 - Omni-Tract®2024-04-05 Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75°
M2483145P1 - Omni-Tract®2024-04-05 Kelly Mod Retractor, 3in x 3in (7.6cm x 7.6cm) Fixed
M2483223P1 - Omni-Tract®2024-04-05 Fence Swivel Blade with 3/8in (1.0cm) Hole, 4in x 5in (10.2cm x 12.7cm)
M268S438A1200B1 - BUDDE®2024-04-05 SAMY™ Vascular Retractor Blade – Long 4.6"
M268S443A1012A1 - BUDDE®2024-04-05 BUDDE® Halo 12 inch (300 mm) Flex Arm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.