FDA.reportPublic FDA data

CODMAN

Primary DI
10886704040231
Brand
CODMAN
Company
CODMAN & SHURTLEFF, INC.
Model
82-1201
Catalog number
821201
Device description
CODMAN Barium Ventricular Catheter 15cm
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704040231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670404023110886704040231

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085355CEREGLIDENIC71115UNIC71115U2023-07-07
10886704085386CEREGLIDENIC71137UNIC71137U2023-07-07
10886704085409CEREGLIDENIC71132UNIC71132U2023-07-07
10886704085423CEREGLIDENIC71125UNIC71125U2023-07-07
10886704078630CODMAN MALIS CMC801788R801788R2016-06-30
10886704046912CODMAN HAKIM RICKHAMNS5068NS50682015-09-20
10886704045366CODMAN HAKIM SIPHONGUARDNS0372NS03722015-09-20
10886704015505CRANIOPLASTIC43-12804312802015-09-20
10886704034995CODMAN FLEX170028700282014-09-20
10886704044598CODMAN HAKIM RICKHAMNS0147NS01472015-09-22
10886704064923MEDSTREAM91-4200US91-4200US2014-09-20
10886704064930MEDSTREAM91-4201US91-4201US2014-09-20
10886704029663TRUFILL DCS ORBIT637HF0204637HF02042015-09-20
10886704043591CODMANAP-03000HAP03000H2014-09-20
10886704043607CODMANAP-03000LAP03000L2014-09-20
10886704043614CODMANAP-03000MAP03000M2014-09-20
10886704043621CODMANAP-03000ULAP03000UL2014-09-20
20886704043826CODMANAP-09150AP091502014-09-20
20886704072888CODMANAP-04009AP040092014-09-20
10886704038689CODMAN80-29078029072016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000422646StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
00763000422684StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
03760409446294Phoenix NeuroSOPHYSAJXG2025-12-24
B775EVACMRI0PHASORPHASOR HEALTH LLCJXG2025-11-24
10381780521051CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535386CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535409CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535416CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535423CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535904CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535966CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535980CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536000CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536024CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536048CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536062CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536086CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536109CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
B775EVAC0PHASORPHASOR HEALTH LLCJXG2025-06-04
04041906505622XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505639XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906505646XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506667XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506674XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506681XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506698XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506704XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506711XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506728XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
04041906506735XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31