FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN® CERTAS®
DI: 10381780536048
·
Model: 828822PL
·
Integra LifeSciences Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CODMAN® CERTAS®
- Primary DI
- 10381780536048
- Version / Model
- 828822PL
- Catalog Number
- 82-8822PL
- Company Name
- Integra LifeSciences Switzerland Sàrl
- Labeler DUNS
- 480186617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 1
- Public Version Date
- 2025-07-08
- Public Version Status
- New
- Public Device Record Key
- 5b382c8d-cdba-427b-9f9b-f40af0cb4df3
Device Description
CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with Accessories and Unitized BACTISEAL® Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35965 | Cerebrospinal fluid shunt valve | An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780536048 | GS1 | ||||
| Previous | 10381780529477 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223330 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No Storage/Handling Values