DuraFuse Dural Clip Instrument Tray

FDA UDI

Class II (US FDA UDI)

by Neuramedica Inc.

Identity

Trade Name: DuraFuse Dural Clip Instrument Tray FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips. FDA UDI
Model / Reference: TR-100 FDA UDI
Description: The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007130427 FDA UDI
FDA Product Code: FZP FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Instrument tray, reusable

DuraFuse Dural Clip Instrument Tray by Neuramedica Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Neuramedica Inc.

Sources (1)

FDA UDI fb3f300c-8e6e-4ab1-9aba-58c4ed375f15 34 fields · synced May 30, 2026