FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ultrasonix Medical Corporation

DI: 08294362000026 · Model: 20.000.000-02 · ANALOGIC CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ultrasonix Medical Corporation
Primary DI
08294362000026
Version / Model
20.000.000-02
Company Name
ANALOGIC CORPORATION
Labeler DUNS
019677418
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-11-17
Public Version
4
Public Version Date
2020-01-28
Public Version Status
Update
Public Device Record Key
953f7791-c76f-491f-be1f-cef6eee69297
Distribution End Date
2019-08-01

Device Description

SonixMDP Q+ Ultrasound System

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IYN System, Imaging, Pulsed Doppler, Ultrasonic
IYO System, Imaging, Pulsed Echo, Ultrasonic

GMDN Terms

Code Name
40761 General-purpose ultrasound imaging system

Identifiers

Type ID
Primary 08294362000026

Customer Contacts