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Unibody™ Bone Fiducials (7mm)

FDA UDI

Class II (US FDA UDI)

by Fhc, Inc.

Identity

Trade Name
Unibody™ Bone Fiducials (7mm) FDA UDI
Generic Name
Neurological stereotactic surgery system FDA UDI
Device Name
Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Stereotactic System FDA UDI
Model / Reference
FM-4007-00773 FDA UDI
Description
Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Stereotactic System FDA UDI

Identifiers

Catalog Number
FM-4007 FDA UDI
Primary DI / UDI-DI
10873263007737 FDA UDI
510(k) Number
K033619 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Neurological stereotactic surgery system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Unibody™ Bone Fiducials (7mm) by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K033619 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fhc, Inc.

Sources (1)

  • FDA UDI 1619c483-488e-48e6-bc08-02b3329a24fc 38 fields · synced May 30, 2026