Identity
- Trade Name
- CODMAN CERTAS® FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve programmer FDA UDI
- Device Name
- CODMAN® CERTAS® X-Ray Overlay Tool FDA UDI
- Model / Reference
- 828859 FDA UDI
- Description
- CODMAN® CERTAS® X-Ray Overlay Tool FDA UDI
Identifiers
- Catalog Number
- 82-8859 FDA UDI
- Primary DI / UDI-DI
- 10381780521334 FDA UDI
- 510(k) Number
- K143111 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid shunt valve programmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cerebrospinal fluid shunt valve programmer
Codman Certas® by Integra LifeSciences Switzerland Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cerebrospinal fluid shunt valve programmer.
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- proSA® — Christoph Miethke GmbH & Co. KG · Class II
- M.BLUE PLUS — AESCULAP, INC. · Class II
- Strata™ — Medtronic PS Medical · Class II
- proGAV® — Christoph Miethke GmbH & Co. KG · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Integra LifeSciences Switzerland Sàrl
Sources (1)
- FDA UDI 9bd86e5a-8c5d-4c36-b5eb-a978ce583f22 36 fields · synced May 30, 2026