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Patient accessory kit

FDA UDI

Class III (US FDA UDI)

by Insightec

Identity

Trade Name
Patient accessory kit FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
UF/Bone1 clinical applications single use treatment kit FDA UDI
Model / Reference
Patient accessory kit for Body FDA UDI
Description
UF/Bone1 clinical applications single use treatment kit FDA UDI

Identifiers

Catalog Number
SET000016 FDA UDI
Primary DI / UDI-DI
07290015461047 FDA UDI
PMA Number
P040003 FDA UDI
P110039 FDA UDI
FDA Product Code
LSY FDA UDI
NRZ 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

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

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

Patient accessory kit 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 85e0d0e5-96fa-4797-9bc1-6793579eda61 37 fields · synced May 30, 2026