FDA.reportPublic FDA data

CODMAN® CERTAS® Plus

Primary DI
10381780535805
Brand
CODMAN® CERTAS® Plus
Company
Integra LifeSciences Switzerland Sàrl
Model
828813PL
Catalog number
82-8813PL
Device description
CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Published
2024-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCACATHETER, VENTRICULAR
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCACatheter, VentricularNeurology2
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223330000Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation2023-02-01JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780529231PreviousGS10
10381780535805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178052923110381780529231
1038178053580510381780535805

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, Keep away from sunlight
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
480186617
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780520610DirectLink™82684082-68402020-04-01
10381780520719CODMAN®82688082-68802020-04-01
10381780520726CODMAN®82688182-68812020-04-01
10381780520733CODMAN®82688282-68822020-04-01
10381780542247CODMAN®9190001GF9190001GF2026-04-15
10381780521433Codman VersaTru™9007050ST9007050ST2020-06-02
10381780521457Codman VersaTru™9007100ST9007100ST2020-06-02
10381780521495Codman VersaTru™9008050SL9008050SL2020-06-02
10381780521518Codman VersaTru™9008050ST9008050ST2020-06-02
10381780521532Codman VersaTru™9008100SL9008100SL2020-06-02
10381780521556Codman VersaTru™9008100ST9008100ST2020-06-02
10381780521570Codman VersaTru™9008150SL9008150SL2020-06-02
10381780521631Codman VersaTru™9009050ST9009050ST2020-06-02
10381780521655Codman VersaTru™9009100SL9009100SL2020-06-02
10381780521693Codman VersaTru™9009150SL9009150SL2020-06-02
10381780521716Codman VersaTru™9009150ST9009150ST2020-06-02
10381780521471Codman VersaTru™9007150ST9007150ST2020-06-02
10381780521594Codman VersaTru™9008150ST9008150ST2020-06-02
10381780521617Codman VersaTru™9009050SL9009050SL2020-06-02
10381780521679Codman VersaTru™9009100ST9009100ST2020-06-02

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
10381780541585CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780541738CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536918CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536925CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780537373CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780537380CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780540748CODMAN® HOLTER®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780541578CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780541745CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
20763000467382NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26