Identity
- Trade Name
- Natus® FDA UDI
- Generic Name
- Peritoneal/atrial cerebrospinal fluid catheter FDA UDI
- Device Name
- Pudenz Reflux Control Catheter FDA UDI
- Model / Reference
- NT8501375 FDA UDI
- Description
- Pudenz Reflux Control Catheter FDA UDI
Identifiers
- Catalog Number
- NT8501375 FDA UDI
- Primary DI / UDI-DI
- 00382830056960 FDA UDI
- 510(k) Number
- K153041 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Peritoneal/atrial cerebrospinal fluid catheter 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
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
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: Peritoneal/atrial cerebrospinal fluid catheter
At Natus Medical Incorporated, we design and manufacture innovative medical devices to help alleviate the burden of excessive cerebrospinal fluid (CSF) accumulation, a condition known as hydrocephalus. Our Pudenz Reflux Control Catheter is a flexible tube intended for implantation in specific patients, offering dual-capability: to channel CSF into either the peritoneal cavity or the right atrium. The device's MR Conditional safety feature ensures optimal performance under magnetic resonance imaging (MRI) conditions, making it an excellent choice for therapeutic use.
Similar devices
Also classified as Peritoneal/atrial cerebrospinal fluid catheter.
- Integra® — Integra Lifesciences Corp. · Class II
- AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
- CODMAN® BACTISEAL® — Integra LifeSciences Production Corporation · Class II
- CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
- Phoenix Neuro — Sophysa SA · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
- CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K153041 also covers:
- Integra Essential Shunt Kit — Integra Lifesciences Corp.
- Integra Essential Shunt Kit — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Novus™ — Integra Lifesciences Corp.
- Novus™ — Integra Lifesciences Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Natus Medical Incorporated
Sources (1)
- FDA UDI 27c041b1-ba2e-4e95-b191-76ddfc9480ee 37 fields · synced Jun 25, 2026