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HistoSonics

FDA UDI

by Histosonics, Inc

Identity

Trade Name
HistoSonics FDA UDI
Generic Name
Combination water purification system FDA UDI
Device Name
Histotripsy Procedure Kit FDA UDI
Model / Reference
HISKT2000 FDA UDI
Description
Histotripsy Procedure Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00850006962129 FDA UDI
GMDN Term
Combination water purification system 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Combination water purification systemTherapeutic oncological/gynaecological ultrasound system

HistoSonics by Histosonics, Inc — 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
Histosonics, Inc

Sources (1)

  • FDA UDI 1be7b6f6-f1bf-482d-88ea-a4e7ee9dca04 35 fields · synced Jun 8, 2026