FDA.report

CODMAN UNI-SHUNT

Primary DI
10886704044482
Brand
CODMAN UNI-SHUNT
Company
CODMAN & SHURTLEFF, INC.
Model
NS0104
Catalog number
NS0104
Device description
CODMAN UNI-SHUNT with Pediatric Reservoir and Shunt 120cm Long Low Closing Pressure 2-5cm H2O Includes: Stylet and Information Manual
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

Related Records

Contact Domains

Product Codes

CodeName
JXGShunt, central nervous system and components

Product Code Classifications

CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886704044482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088670404448210886704044482

GMDN Terms

TermDefinition
Ventriculoperitoneal shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the ventricles (fluid-filled cavities) of the brain to the peritoneal cavity, where it can be absorbed into the body. It typically consists of three main parts: 1) a ventricular catheter with holes which allow the CSF to drain through the catheter and to; 2) a mechanical ventriculoperitoneal (VP) shunt valve that typically opens at a pre-set pressure; and 3) a distal catheter that channels the CSF to the peritoneal cavity. This device is intended as a therapeutic measure for situations where increased CSF causes increased intracranial pressure (hydrocephalus).

Sterilization Methods

Method

Contacts

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 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 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