Identity
- Trade Name
- Natus® FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve FDA UDI
- Device Name
- Spetzler™ In-Line Valve (Medium Pressure) FDA UDI
- Model / Reference
- NT8507421 FDA UDI
- Description
- Spetzler™ In-Line Valve (Medium Pressure) FDA UDI
Identifiers
- Catalog Number
- NT8507421 FDA UDI
- Primary DI / UDI-DI
- 00382830057240 FDA UDI
- 510(k) Number
- K161992 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid shunt valve 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Cerebrospinal fluid shunt valve
Natus® by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — 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
K161992 also covers:
- Integra Spetzler™ Lumbar Peritoneal Shunt System — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Spetzler™ — Integra Lifesciences Corp.
- Natus® — Natus Medical Incorporated
- Natus® — Natus Medical Incorporated
- Natus® — Natus Medical Incorporated
- Natus® — Natus Medical Incorporated
- Natus® — Natus Medical Incorporated
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
- Natus Medical Incorporated
Sources (1)
- FDA UDI c8b1102c-ef10-4fb2-a488-0c8fba672b9d 37 fields · synced Jun 8, 2026