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Hfd100

FDA UDI

Class II (US FDA UDI)

by IMRIS Imaging, Inc.

Identity

Trade Name
HFD100 FDA UDI
Generic Name
Skull clamp FDA UDI
Device Name
Head Fixation Device HFD100 - ORT 400 METRIC FDA UDI
Model / Reference
119630-000 FDA UDI
Description
Head Fixation Device HFD100 - ORT 400 METRIC FDA UDI

Identifiers

Primary DI / UDI-DI
00857534006615 FDA UDI
510(k) Number
K103493 FDA UDI
FDA Product Code
HBL FDA UDI
GMDN Term
Skull clamp FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4460 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Skull clamp

Hfd100 by IMRIS Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skull clamp.

Cleared under the same submission

K103493 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IMRIS Imaging, Inc.

Sources (1)

  • FDA UDI 0dbe2abf-0461-4491-89dd-25acec72e4b7 34 fields · synced May 29, 2026