Ventricular Catheter 14M02

GUDID 10381780034674

The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with full barium impregnation. Numbered length markers are located 5 and 10 cm from the proximal end. Length marker dots are located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end presents thirthy-two (32) flow holes. The proximal tip is constructed of molded, barium sulfate impregnated silicone to provide smooth, consistent end, which aid catheter placement. A stainless steel stylet and a right angle guide are provided.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Intracerebral infusion/drainage catheter, long-term
Primary Device ID10381780034674
NIH Device Record Key0982a280-b94a-4606-bc22-f9412cd0369e
Commercial Distribution Discontinuation2021-06-30
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentricular Catheter
Version Model Number14M02
Catalog Number14M02
Company DUNS531408342
Company NameINTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
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

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 Identifiers

Device Issuing AgencyDevice ID
GS110381780034674 [Primary]
HIBCCM27214M021 [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 Date2019-12-20
Device Publish Date2015-10-01

On-Brand Devices [Ventricular Catheter]

10381780034674The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with full ba
1038178003333220 cm Radiopaque Straight Ventricular Catheter with large holes and graphite based length marks
10381780035640Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035633Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780034230Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780034223Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035947Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035930Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035923Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035916Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035909Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035893Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035886Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035879Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035862Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035855Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
10381780035695The marked Straight Ventricular Catheter (inner diameter 1.4mm, outer diameter 2.7mm) features r
10381780035688Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer
M2729MD10221Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer

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