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Sonablate Insertion Pack

FDA UDI

by Focus Surgery, Inc.

Identity

Trade Name
Sonablate Insertion Pack FDA UDI
Generic Name
Invasive ultrasound transducer cooling/coupling support kit FDA UDI
Device Name
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit. FDA UDI
Model / Reference
403-02200-0002 FDA UDI
Description
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit. FDA UDI

Identifiers

Primary DI / UDI-DI
00868108000281 FDA UDI
GMDN Term
Invasive ultrasound transducer cooling/coupling support kit FDA UDI

Classification

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

No

FDA UDI

Category: Invasive ultrasound transducer cooling/coupling support kit

Sonablate Insertion Pack by Focus Surgery, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive ultrasound transducer cooling/coupling support kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Focus Surgery, Inc.

Sources (1)

  • FDA UDI eec50f49-e2d7-49fa-b88c-b6535417232a 33 fields · synced May 31, 2026