Identity
- Trade Name
- CODMAN® HAKIM® EUDAMEDFDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve FDA UDI
- Device Name
- Precision Valve EUDAMEDPrecision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device and Unitized Catheter High Range FDA UDI
- Model / Reference
- 82-3824 EUDAMED823824 FDA UDI
- Description
- Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device and Unitized Catheter High Range FDA UDI
Identifiers
- Catalog Number
- 82-3824 FDA UDI
- Primary DI / UDI-DI
- 10381780535010 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10381780535010 EUDAMED
- 510(k) Number
- K221840 FDA UDI
- FDA Product Code
- JXG FDA UDI
- EMDN Code
- N010301 VENTRICULAR-PERITONEAL SHUNTS EUDAMED
- GMDN Term
- Cerebrospinal fluid shunt valve FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Cerebrospinal fluid shunt valve
Codman® Hakim® by Integra LifeSciences Production Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cerebrospinal fluid shunt valve.
- Mini Integra® — Integra Lifesciences Corp. · Class II
- BioGlide® — Medtronic PS Medical · Class II
- UltraVS™ — Integra Lifesciences Corp. · Class II
- Integra® — Integra Lifesciences Corp. · Class II
- Delta® — Medtronic PS Medical · Class II
- Strata® — Medtronic PS Medical · Class II
- GAV 2.0 — AESCULAP, INC. · Class II
- miniNAV® — Christoph Miethke GmbH & Co. KG · Class II
Cleared under the same submission
K221840 also covers:
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (2)
- FDA UDI 4a97763d-36ed-41a3-ba5f-56e95e0e7c55 37 fields · synced Oct 7, 2026
- EUDAMED 154083e1-24af-44f6-b011-b3305d8970d6 61 fields · synced Oct 7, 2026