Natus®

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name: Natus® FDA UDI
Generic Name: Cranial port/reservoir FDA UDI
Device Name: BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - Ø 6.4 mm - Depth 2.5 mm) FDA UDI
Model / Reference: NT955110 FDA UDI
Description: BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - Ø 6.4 mm - Depth 2.5 mm) FDA UDI

Identifiers

Catalog Number: NT955110 FDA UDI
Primary DI / UDI-DI: 00382830055192 FDA UDI
510(k) Number: K152897 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Cranial port/reservoir 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cranial port/reservoir

Natus® by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CODMAN® HOLTER® RICKHAM® — Integra LifeSciences Production Corporation · Class II
AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
CODMAN® HOLTER® SELKER — Integra LifeSciences Production Corporation · Class II
CODMAN® HOLTER® SALMON™-RICKHAM® — Integra LifeSciences Production Corporation · 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: Natus Medical Incorporated

Sources (1)

FDA UDI 0695ef8b-2ca0-4d45-87b7-035edf20e49d 37 fields · synced May 29, 2026