FDA.reportPublic FDA data

Codman® CerebroFlo®

Primary DI
10381780530138
Brand
Codman® CerebroFlo®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
37.550.501
Catalog number
37.550.501
Device description
Codman® CerebroFlo® EVD Catheter Set With Endexo® Technology Contains 5 Sets
Published
2022-02-25
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
K170599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170599000SureFlo EVD CatheterArkis Biosciences, Inc.2017-08-31JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780530132PackageGS15In Commercial Distribution
10866614000105PreviousGS10
10381780530138PrimaryGS10
00381780530131Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038178053013230381780530132
1086661400010510866614000105
1038178053013810381780530138
00381780530131003817805301313817805301310381780530131

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral infusion/drainage catheter, short-termA flexible tube intended to be surgically inserted through the skull for short-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 may also be intended for measurement of intracranial pressure (ICP). 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, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter
Outer Diameter3.3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Use if Package is Damaged

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
5
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02
10381780519089CODMAN® HAKIM®82309782-30972020-06-02
10381780519195CODMAN® HAKIM®82311682-31162020-06-02
10381780519249CODMAN® HAKIM®82316482-31642020-06-02
10381780519256CODMAN® HAKIM®82318282-31822020-06-02
10381780519263CODMAN® HAKIM®82318482-31842020-06-02
10381780519447CODMAN® HAKIM®82328182-32812020-06-02
10381780519478CODMAN® HAKIM®82328482-32842020-06-02
10381780519485CODMAN® HAKIM®82328582-32852020-06-02
10381780519751CODMAN® HAKIM®82382182-38212020-06-02
10381780519768CODMAN® HAKIM®82382282-38222020-06-02
10381780519799CODMAN® HAKIM®82382582-38252020-06-02
10381780519805CODMAN® HAKIM®82383282-38322020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760409440285SophysaSOPHYSAJXG2026-06-22
03760409440308SophysaSOPHYSAJXG2026-06-22
03760409440315SophysaSOPHYSAJXG2026-06-22
03760409440322SophysaSOPHYSAJXG2026-06-22
03760409441121SophysaSOPHYSAJXG2026-06-05
03760409441138SophysaSOPHYSAJXG2026-06-05
03760409441145SophysaSOPHYSAJXG2026-06-05
03760409441152SophysaSOPHYSAJXG2026-06-05
03760409441169SophysaSOPHYSAJXG2026-06-05
03760409441176SophysaSOPHYSAJXG2026-06-05
03760409441183SophysaSOPHYSAJXG2026-06-05
03760409441190SophysaSOPHYSAJXG2026-06-05
03760409441206SophysaSOPHYSAJXG2026-06-05
03760409441213SophysaSOPHYSAJXG2026-06-05
03760409441220SophysaSOPHYSAJXG2026-06-05
03760409441237SophysaSOPHYSAJXG2026-06-05
03760409441244SophysaSOPHYSAJXG2026-06-05
03760409441251SophysaSOPHYSAJXG2026-06-05
03760409441268SophysaSOPHYSAJXG2026-06-05
10381780540748CODMAN® HOLTER®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
20763000467382NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
10381780533900CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534006CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534013CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534020CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534037CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534044CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2023-07-13
10381780534051CODMAN® HAKIM®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2022-11-14
00763000624798Duet®MEDTRONIC PS MEDICAL, INC.JXG2022-03-10