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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
Support Arm FDA UDI
Model / Reference
EDNSA1001 FDA UDI
Description
Support Arm FDA UDI

Identifiers

Primary DI / UDI-DI
00850006962044 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Histosonics, Inc

Sources (1)

  • FDA UDI 4117bdc0-5125-4b5e-a58e-b472c5e68ce1 35 fields · synced Jun 1, 2026