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Edison

FDA UDI

Class II (US FDA UDI)

by Histosonics, Inc

Identity

Trade Name
Edison FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
Treatment Cart FDA UDI
Model / Reference
EDNTC1001 FDA UDI
Description
Treatment Cart FDA UDI

Identifiers

Primary DI / UDI-DI
00850006962006 FDA UDI
FDA Product Code
QGM FDA UDI
GMDN Term
Therapeutic oncological/gynaecological ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4405 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

Category: Therapeutic oncological/gynaecological ultrasound system

Edison by Histosonics, Inc — Class II — 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 cd93e5da-5023-4b9e-b9a4-19dff8a91705 35 fields · synced May 30, 2026