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Ex Neuro Patient Treatment Kit 3.0t W\o Coil (5) Non-Ce

FDA UDI

Class III (US FDA UDI)

by Insightec

Identity

Trade Name
EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
ExAblate 4000 (Neuro) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE The membrane and DQA are for 5 treatment reuse FDA UDI
Model / Reference
SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE FDA UDI
Description
ExAblate 4000 (Neuro) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE The membrane and DQA are for 5 treatment reuse FDA UDI

Identifiers

Catalog Number
SET001043 FDA UDI
Primary DI / UDI-DI
07290019402305 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

Yes

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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Therapeutic oncological/gynaecological ultrasound system

Ex Neuro Patient Treatment Kit 3.0t W\o Coil (5) Non-Ce by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic oncological/gynaecological ultrasound system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insightec

Sources (1)

  • FDA UDI d0ac52db-a20f-4bb4-9890-b9415fcb158f 36 fields · synced Jun 8, 2026