DuraFuse Dural Clip Applier

FDA UDI

Class II (US FDA UDI)

by Neuramedica Inc.

Identity

Trade Name: DuraFuse Dural Clip Applier FDA UDI
Generic Name: Open-surgery ligation clip applier FDA UDI
Device Name: The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips. FDA UDI
Model / Reference: AP-100 FDA UDI
Description: The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007130410 FDA UDI
FDA Product Code: FZP FDA UDI
GMDN Term: Open-surgery ligation clip applier 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: Open-surgery ligation clip applier

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

Similar devices

Also classified as Open-surgery ligation clip applier.

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WECK — TELEFLEX INCORPORATED · Class I
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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 28da81a5-a83d-4e61-99a9-4122446e4cfe 34 fields · synced Jun 8, 2026