Integra®

Primary DI
10381780024460
Brand
Integra®
Company
Integra Lifesciences Corporation
Model
NL97005S01
Catalog number
NL97005S01
Device description
5 FRENCH T-TUBEThe Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide continuous drainage of fluid from within a spinal cord cyst to a site outside the spinal canal. The T-tube diameter is small to minimize the size of the myelotomy and the catheter is flexible to minimize the spinal cord manipulation necessary to insert the tube into a spinal cord cyst. The T-shape allows drainage above and below the myelotomy site, helps prevent kinking by providing a right-angle exit through the dura, and reduces the risk of migration out of the spinal cord. The multi-holed catheter reduces the risk of clogging at the spinal end of the system. The suture tab allows the T-tube to be anchored to the dura or paraspinous muscles without the risk of shunt occlusion associated with a circumferential ligature. If a step down connector is used, it adapts the T-tube diameter to the peritoneal reflux control catheter.
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854049000HEYER-SCHULTE SYRINGO PERITONEAL SHUNTAmerican V. Mueller1985-11-27JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780024460PrimaryGS10
M269NL97005S011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178002446010381780024460

GMDN Terms#

Term, Definition table
TermDefinition
Lumboperitoneal shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity, where it can be absorbed into the body, as a treatment for elevated intracranial pressure due to increased CSF. It typically consists of fully-implanted interconnected components that include a spinal catheter implanted into the subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a reservoir which can be punctured for sampling/infusion; and a peritoneal catheter implanted into the peritoneal cavity. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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