FDA.reportPublic FDA data

CODMAN® BACTISEAL®

Primary DI
10381780526803
Brand
CODMAN® BACTISEAL®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
NS5525
Catalog number
NS5525
Device description
CODMAN® BACTISEAL® Ventricular Catheter with Centimeter Markings with BACTISEAL® Shunt System
Published
2020-05-11
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
HCACATHETER, VENTRICULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCACatheter, VentricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003322000CODMAN BACTISEAL CATHETERSCodman & Shurtleff, Inc.2001-10-01HCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780526803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178052680310381780526803

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral infusion/drainage catheter, long-termA sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Use if Package is Damaged
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit81 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535805CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535843CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780536970CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780536987CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780536994CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537007CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537014CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537021CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537038CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537045CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537052CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537069CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537076CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537083CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537106CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537113CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537120CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537137CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537144CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537151CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
00763000028961Innervision, BioGlide®MEDTRONIC PS MEDICAL, INC.HCA2020-08-21
00763000333614Exacta™MEDTRONIC PS MEDICAL, INC.HCA2020-06-08
10381780521136CODMAN CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2020-06-03
10381780511540CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2020-04-01
10381780511557CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2020-04-01