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Headframe Pfk Type 1.1 Fda/Row Integra (fmi)

FDA UDI

Class III (US FDA UDI)

by Insightec

Identity

Trade Name
HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI) FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK FDA UDI
Model / Reference
SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI) FDA UDI
Description
HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK FDA UDI

Identifiers

Catalog Number
SET400168-AE FDA UDI
Primary DI / UDI-DI
07290019402466 FDA UDI
PMA Number
P150038 FDA UDI
FDA Product Code
POH FDA UDI
GMDN Term
Therapeutic oncological/gynaecological ultrasound system FDA UDI

Classification

Device Class
Class III 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Therapeutic oncological/gynaecological ultrasound system

Headframe Pfk Type 1.1 Fda/Row Integra (fmi) by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic oncological/gynaecological ultrasound system.

Cleared under the same submission

P150038 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insightec

Sources (1)

  • FDA UDI 922384ab-9b62-4804-9fda-fdf3bfc0c8b5 37 fields · synced May 30, 2026