Suturable Tubing Clamp 999004

GUDID 10381780034445

The Integra Suturable Tubing Clamps are sterile single use devices designed to secure a ventricular or a lumbar catheter to the surrounding tissues by means of non-absorbable suture. They consist of a butterfly shaped radiopaque silicone tubing with two suture holes. They feature a slit for introduction of the catheter. They are available in three inner diameters to anchor Integra NeuroSciences catheters presenting a F5 (OD=1.65mm), F7 (OD=2.25mm), or F8 (OD=2.65mm) outer diameter (OD).

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Intracranial catheter holder
Primary Device ID10381780034445
NIH Device Record Key5f916661-2c09-4eb2-ad25-48cc403ac64d
Commercial Distribution Discontinuation2021-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSuturable Tubing Clamp
Version Model Number999004
Catalog Number999004
Company DUNS531408342
Company NameINTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780034445 [Primary]
GS130381780034449 [Package]
Package: BOX [5 Units]
Discontinued: 2021-06-30
Not in Commercial Distribution
HIBCCM2729990041 [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 Date2023-02-17
Device Publish Date2015-10-01

On-Brand Devices [Suturable Tubing Clamp]

10381780034469The Integra Suturable Tubing Clamps are sterile single use devices designed to secure a ventricu
10381780034452The Integra Suturable Tubing Clamps are sterile single use devices designed to secure a ventricu
10381780034445The Integra Suturable Tubing Clamps are sterile single use devices designed to secure a ventricu

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