FDA.reportPublic FDA data

CODMAN CERTAS SIPHONGUARD BACTISEAL

Primary DI
10886704079071
Brand
CODMAN CERTAS SIPHONGUARD BACTISEAL
Company
Medos International Sàrl
Model
82-8807PL
Catalog number
828807PL
Device description
CODMAN CERTAS Plus Programmable Valve Inline Valve with SIPHONGUARD, Accessories and Unitized BACTISEAL Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
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
K143111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143111000Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL2015-02-19JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704079071PreviousGS10
10381780521280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670407907110886704079071
1038178052128010381780521280

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculo-peritoneal/atrial shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the ventricles (fluid-filled cavities) of the brain to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It typically consists of a ventricular catheter, a mechanical shunt valve, and a distal catheter(s) that channels the CSF to the peritoneal cavity or right atrium. This device is intended as a therapeutic measure for situations where increased CSF causes increased intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius27 Degrees Celsius
Handling Environment Temperature36 Degrees Fahrenheit81 Degrees Fahrenheit
Special Storage Condition, Specify00Do Not Use if Package is Damaged
Special Storage Condition, Specify00Keep Away From Sunlight, Do 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
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10381780535362CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535379CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535881CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535928CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535942CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780536734CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536741CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536758CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536765CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536789CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536819CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29